Recall Z-2066-2017 ยท LZP Aid, Surgical, Viscoelastic
Abbott Medical Optics Inc. (AMO)
Healon Pro, Part No. 10270012
| Date | Apr 1, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | A recall letter was sent to customers on 4/1/17 to inform them that AMO has voluntarily initiated this Action because a remote possibility exists that certain Healon OVD solutions in the affected lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. Use of OVD solutions with glass particles could potentially lead to intraocular injury. Customers are instructed to complete the Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to RegCompliOne@abbott.com within 3 business days of receipt of t |
| Quantity | 293,867 units total |
| Distribution | 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 Malay |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.