Alcon Custom Pak Intraocular Lens Packages Recalled for Plastic Debris Risk
Alcon Custom Pak intraocular lens packages are recalled due to reports of patient injury during surgical procedures caused by plastic debris from over-tightening with the included plastic wrench.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II device with reported patient injuries occurring during surgical procedures. The source confirms injuries were reported, meeting the rubric criterion for significant injury reports in a Class II device recall.
Plain-English summary
Alcon is recalling Custom Pak intraocular lens packages due to reports of patient injuries occurring during surgical procedures. The hazard is potential plastic debris that can be generated when the device is over-tightened with the included plastic wrench.
The recalled devices were distributed worldwide, including throughout the United States and more than 100 countries globally. Affected devices are identified by a series of catalog numbers as listed by the FDA.
Patients who have received this device or healthcare providers using these products should contact Alcon or their medical supplier for guidance regarding recalled inventory and appropriate next steps.
The recalled product
- Product
- Alcon Custom Pak
- Manufacturer
- Alcon Research, LTD.
- Affected units
- 1,682,351
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog No. Catalog #
- 0007-67
- 0091-69
- 0210-70
- 0302-82
- 0349-78
- 0365-75
- 0437-38
- 0680-74
- 0693-66
- 0781-63
- 0815-68
- 0880-41
- 0888-69
- 0900-28
- 0938-60
- 0956-69
- 0995-82
- 10008-16
- 10014-63
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Alcon Research, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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