FIELD SAFETY NOTICE (FSN) - URGENT FIELD SAFETY CORRECTIVE ACTION
FIELD SAFETY NOTICE (FSN)
URGENT FIELD SAFETY CORRECTIVE ACTION
Theft of Distribution-Controlled Medical Device Shipment
FSCA Reference: LP007058
Date: 24 July 2026
1. Product Information and Classification
PRODUCT TRADE NAME The Eye Doctor Advanced Triple Acon Eye Drops 10ml
PRODUCT IDENTIFYING F0017
TYPE NUMBER
UK IMPORTER / DISTRIBUTOR The Body Doctor Ltd
MANUFACTURER Oy Finnsusp Ab
UK REPRESENTATIVE Emergo consulting (UK) Limited
COMPOSITION 0.1 % sacha inchi seed oil (Plukenetia volubilis), 2 % trehalose, 0.2 %
high-molecular-weight hyaluronic acid, glycerol, and emulsifiers polyoxyethylene sorbitan monooleate, and sorbitan monooleate in sterile and hypotonic trometamol /citrate buffer emulsion
INTENDED USE OF THE PRODUCT The product is a sterile, preservative-free lipid microemulsion eye drop for the treatment and prevention of signs and symptoms of
moderate to severe dry eye, filled in a 10 mL multidose bottle.
PRODUCT CLASSIFICATION Medical device risk classification IIb. Legacy device.
The product is placed on the Great Britain market as a CE-marked device in accordance with the transitional arrangements set out in the Medical Devices Regulations 2002 (SI 2002/618, as amended), which permit devices covered by the transitional provisions of Article 120(3) of Regulation (EU) 2017/745 to continue to be placed on the market.
LOT NUMBER CONCERNED A1127
EXPIRY DATE 04/2028
MANUFACTURING DATE 04/2026
QUANTITY 24,230 pcs
PRODUCT IMAGES At the end of this document
MARKET TERRITORY UK and Ireland
2. Reason for this Field Safety Notice
The manufacturer is issuing this Field Safety Notice following the confirmed theft of an entire shipment of the above medical device during transportation. The affected shipment has not reached the authorised distributor and its current whereabouts are unknown.
As the products are outside the manufacturer's controlled distribution chain, their storage conditions, handling, transportation and possible subsequent distribution cannot be verified. Consequently, the manufacturer cannot guarantee that the affected products continue to comply with the specified quality, safety and performance requirements.
This FSN is intended to prevent the use or distribution of products originating from the stolen shipment.
3. Description of the Incident
The complete shipment consisting of 24,230 units from the affected batch was dispatched from the manufacturer on 4 June 2026.
According to information subsequently received from the transportation company, the shipment was stolen in the United Kingdom before delivery to the authorised distributor. The products were transported on wooden pallets. During the theft, the complete wholesale boxes were removed from the pallets and stolen intact.
The whole batch was dispatched to and intented to be distributed by The Body Doctor Ltd in the territory of UK and Ireland. The batch has not been distributed elsewhere.
Each product is packaged as follows:
- Sterile multidose 10 mL bottle with product label
- Bottle packed into an individual labelled carton
- Ten cartons bundled in transparent labelled wrapping
- Twelve bundles packed into one labelled wholesale shipping box
See images at the end of this document.
No evidence currently indicates that any products have entered the authorised supply chain.
4. Hazard Giving Rise to the FSCA
Products originating from the stolen shipment may have been exposed to uncontrolled transportation or storage conditions.
Potential hazards associated with the affected products:
1. Unknown storage conditions may result in reduced product quality or performance and local ocular irritation or discomfort.
2. Use beyond the recommended discard period may cause local irritation or discomfort or, in rare cases, eye infection due to microbial contamination of the contents.
3. Manipulation or tampering of the primary package may lead to eye infection due to microbial contamination of the contents.
4. Off-label or non-compliant use may delay the diagnosis and treatment of an underlying ophthalmic condition, as symptom relief may mask disease progression.
Probabilities of problem arising:
1. Probable,
2. Probable, remote (microbiological),
3. Occasional,
4. Occasional.
Predicted risk to patient/users:
The risks identified for the stolen batch, should it be placed on the market outside the authorised distribution network, all fall within the investigate-further-risk-reduction (IFRR) area, with the exception of off-label use, which remains at an acceptable level. To mitigate these risks, the FSN has been issued to prevent the unauthorised distribution and use of batch A1127.
Further information to help characterise the problem:
Any product obtained outside the authorised distribution network should be considered potentially compromised. The stolen batch can be identified by lot number A1127, which appears on the bottle label, the carton box, the 10-piece plastic bundle label, and the wholesale carton boxes.
5. Advice on Action to be Taken by Customers, Distributors and Healthcare facilities
Customers, distributors and healthcare facilities are requested to:
1. Verify whether they possess products from the affected lot.
2. Do not use, distribute or supply products from the affected batch, since their origin cannot be confirmed through the authorised distribution chain.
3. Do not purchase products from unofficial sources or online marketplaces if the origin cannot be verified.
4. Immediately quarantine any affected products. If possible, quarantine the affected lot in advance in the ERP system or similar, although not possessing the products.
5. Notify the manufacturer immediately if products from the affected lot are identified.
6. Report any suspected adverse events associated with the affected products according to local vigilance
requirements.
By when should the action be completed?
Potentially the stolen batch can unauthorisedly be placed on the market until the expiry date of the batch, i.e. April 2028. 01.05.2028.
Is customer reply required?
Yes. When replying, please use the provided FSN Acknowledgement form.
6. Actions Taken by the Manufacturer
The manufacturer has implemented / is implementing the following actions: Communication to the relevant Competent Authorities, Notified Body, UKRP and the customer on the theft of the batch A1127. Evaluation of the logistics process. Post-market-surveillance and possible vigilance reporting concerning the batch A1127.
By when should the action be completed?
Expiry date of the batch, i.e. April 2028. 01.05.2028.
Is the FSN required to be communicated to the patient /lay user?
No. Communication to the distribution chain is sufficient.
7. Competent Authority Notification
Has the Competent (Regulatory) Authority of your country been informed about this communication to customers?
Yes, the Finnish Competent Authority Fimea was informed 3 July 2026.
8. Distribution of this Notice
This Field Safety Notice should be forwarded to all persons and organisations within the distribution chain who may have received, purchased or otherwise obtained the affected products. Notification of the distribution chain is considered sufficient; no direct communication to end users is required.
Please maintain awareness of this notice until all actions have been completed.
9. Manufacturer Statement
Oy Finnsusp Ab sincerely regrets any inconvenience caused by this incident.
Patient safety remains our highest priority. This Field Safety Notice has been initiated to minimise any potential risk associated with products originating from the stolen shipment.
Actions required from the Recipient of this FSN:
Please confirm the receipt of this FSN by filling and returning the filled Field Safety Notice Acknowledgement Form attached.
Contact Information
Manufacturer
Oy Finnsusp Ab
Address: Pääskykalliontie 5, 21420 Lieto, Finland
Telephone: +358 50 3723787
Email: quality@piiloset.fi
Lieto, 24th July 2026
Heidi Hirviniemi
Quality Director
Oy Finnsusp Ab
