Abbott Medical Optics Inc. (AMO): Medical Device Recall in 2017 - (Recall #: Z-2063-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014

Product Classification:

Class II

Date Initiated: April 1, 2017

Date Posted: May 17, 2017

Recall Number: Z-2063-2017

Event ID: 77023

Reason for Recall:

Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.

Status: Terminated

Product Quantity: 293,867 units total

Code Information:

UB32596, UB32571, UB32597, UB32577, UB32576

Distribution Pattern:

US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malaysia Singapore South Korea Taiwan Thailand Japan Chile Colombia Costa Rica Ecuador

Voluntary or Mandated:

Voluntary: Firm initiated