Ophthalmic surgical packs recalled over incomplete seals affecting sterility
Alcon Research is recalling 151 Custom Pak ophthalmic procedure packs because the packs may have incomplete seals affecting sterility. The FDA has classified the action as Class I.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
Alcon Custom Paks, described in the record as customer-designed sterile surgical packs, are being recalled by Alcon Research LLC. Affected catalog numbers include 9903-20, 17188-04, 19762-03, 19203-04 and 17957-10.
Ophthalmic procedure packs may have incomplete seals affecting sterility.
The record lists 151 units, with UDI and lot details recorded in the enforcement record including lot 17PJ9X for 9903-20, lot 17PJAY for 17188-04 and lot 17PU09 for 19762-03. Distribution was nationwide in the United States, in California, North Dakota and Utah. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine affected lots immediately and follow Alcon's instructions.
The recalled product
- Product
- Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience…
- Manufacturer
- Alcon Research LLC
- Category
- Medical Device — Procedure tray
- Affected units
- 151
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 (6)
- UDI: *+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X
- 17188-04 - Lot # 17PJAY
- 19762-03 - Lot # 17PU09
- 19203-04- Lot # 17PMWE
- 19203-04 - Lot # 17PTXP
- 17957-10- Lot #17PTXY
Distribution
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