MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-25 for ACRYSOF MULTIPIECE IOL MA50BM MA50BM.190 manufactured by Alcon Research, Llc - Huntington.
[186812218]
Evaluation summary: the product was not returned for analysis. The product history and batch records were reviewed and documentation indicated the product met release criteria. The product investigation could not identify a root cause. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186812219]
A facility representative reported that an intraocular lens (iol) was implanted in the morning and later they realized that the iol was damaged/broken. The patient went back to surgery that afternoon to have the iol replaced. The second iol was also damaged when implanted. The second iol was also removed. Additional information was provided indicating that the haptics are coming off of the iols when gluing or suturing them in. Both iols had haptics break. The first iol was removed in a secondary procedure later that same day. The second iol (replacement) haptic also broke after insertion and the iol was removed during that iol exchange procedure the same day. This report is for the first iol that had a damaged/broken haptic and removed in a secondary procedure later that same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2020-00510 |
| MDR Report Key | 9881294 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2018-09-05 |
| Date Added to Maude | 2020-03-25 |
| 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 | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| 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 | 2020-03-25 |
| Model Number | MA50BM |
| Catalog Number | MA50BM.190 |
| Lot Number | 12647423 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-25 |