Abbott Recalls Healon GV Due to Possible Microscopic Glass Particles
Abbott Medical Optics is recalling Healon GV due to a remote possibility of microscopic glass particles from manufacturing damage.
What this means for you
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, and the hazard is described as a 'remote possibility,' fitting the High severity criteria for theoretical or unreported harm.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling specific lots of Healon GV, a medical device solution. The recall involves part numbers 10294701, 10294801, 10200014, 10201014, 10202014, and 10203014, with a total of 293,867 units affected. The product was distributed in the United States and worldwide, including numerous countries in Europe, Asia, the Middle East, and the Americas.
The reason for the recall is a remote possibility that certain solutions in these lots may contain microscopic glass particles. This potential contamination is attributed to damage that occurred at the cylinder neck during the manufacturing process.
Healthcare providers and patients should check their inventory and records for the affected part numbers and lot codes (UB32596, UB32571, UB32597, UB32577, UB32576). If these specific units are found, they should be stopped from use and returned to Abbott Medical Optics or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Affected units
- 293,867
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 (5)
- UB32596
- UB32571
- UB32597
- UB32577
- UB32576
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Abbott Medical Optics Inc. (AMO) 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.
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