Alcon Surgical Procedure Packs Recalled for Adhesive Defect and Skin Injuries
Alcon is recalling Custom Pak Surgical Procedure Packs because the adhesive liner is difficult to remove and the manufacturer has observed an increase in skin injuries related to the adhesive.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with reported adhesive-related skin injuries observed by the manufacturer. No hospitalization is mentioned, so this does not meet the criteria for Severe classification.
Plain-English summary
Alcon Research, LLC is recalling the Custom Pak Surgical Procedure Pack, a sterile surgical supply kit used during eye surgeries. The recall affects 308,610 kits that were distributed worldwide, including to all U.S. states and multiple foreign countries.
The recall was initiated due to two identified issues with the adhesive components of the surgical drapes included in these packs. The adhesive liner is difficult to remove, potentially rendering the product unusable. Additionally, the manufacturer has reported an increase in adhesive-related skin injuries associated with the affected product lots.
Healthcare facilities and hospitals that received these Custom Pak Surgical Procedure Packs should stop using the affected lots and contact Alcon Research for instructions on product return or replacement. The FDA classified this as a Class II recall. Patients or healthcare workers who experienced skin injuries potentially related to this product should consult with their healthcare provider.
The recalled product
- Product
- Alcon Custom Pak Surgical Procedure Pack
- Manufacturer
- Alcon Research, LLC
- Category
- Medical Device — Surgical Drapes
- Affected units
- 308,610
Distribution
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