Recall Z-2676-2024 ยท HQC Unit, Phacofragmentation
Alcon Research LLC
Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A
| Date | Aug 16, 2024 (initiated Jul 15, 2024) |
| Status | Open, Classified |
| Reason | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. |
| Root cause | Process control |
| Action | On July 15, 2024, URGENT: MEDICAL DEVICE FIELD CORRECTION letters were sent to customers. Actions to be taken by the Customer / User: Our records indicate that you have received affected sterile standalone knives/trocar entry systems, Vitrectomy/Combined Procedure Pak, or an Alcon Custom Pak with an affected knives/trocar entry system lot number. 1. If you received sterile standalone knives or trocar entry system, we are asking that you dispose of the affected ophthalmic knife/trocar entry system and use a replacement. Alcon is sending sufficient replacement quantities to cover your estimated |
| Quantity | 7,108 units |
| Distribution | Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Ma |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.