The Alcon Custom Pak — Class II medical device recall Z-1702-2015
Terminated recall by Alcon Research, Ltd., reported 2015-06-10, distributed nationwide. The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the pot
| Recall number | Z-1702-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2015-04-28 |
| Classified | 2015-06-02 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 219,680 units |
Product
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
Reason for recall
The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1702-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.