MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-05-30 for ACRYSOF MULTIPIECE IOL MA60AC MA60AC.185 manufactured by Alcon Research, Llc - Huntington.
[146499655]
Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Cartridge product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. There has been two other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146499656]
A facility representative reported that during an intraocular lens (iol) implant procedure, the surgeon noted the lens was very stiff and was unable to manipulate into the cartridge or fold the lens with folding forceps. An enlarged incision was required to complete the procedure. The sample is available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2019-00791 |
| MDR Report Key | 8653944 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-05-30 |
| Date of Report | 2019-09-11 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-08-18 |
| Device Manufacturer Date | 2015-09-09 |
| Date Added to Maude | 2019-05-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | ALCON RESEARCH, LLC - HUNTINGTON |
| Manufacturer Street | 6065 KYLE LANE |
| Manufacturer City | HUNTINGTON WV 25702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 25702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACRYSOF MULTIPIECE IOL |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HQL |
| Date Received | 2019-05-30 |
| Returned To Mfg | 2019-07-20 |
| Model Number | MA60AC |
| Catalog Number | MA60AC.185 |
| Lot Number | 12399173 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - HUNTINGTON |
| Manufacturer Address | 6065 KYLE LANE HUNTINGTON WV 25702 US 25702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-30 |