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 2020-02-13 for ENVISTA TORIC INTRAOCULAR LENS MX60TP MX60TP575+250 manufactured by Bausch + Lomb.
[183718426]
The product has been returned and is pending evaluation. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[183718427]
It was reported that during the insertion of an intraocular lens (iol) there was a lens folding issue with the leading haptic. The incision was enlarged to remove the lens intraoperatively, and sutures were required. Though requested, no additional information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00032 |
| MDR Report Key | 9707619 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-13 |
| Date of Report | 2019-10-23 |
| Date of Event | 2019-10-08 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-02-13 |
| 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 | STEPHANIE ANASTASIOU |
| Manufacturer Street | 21 NORTH PARK PLACE BLVD. |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal | 33759 |
| Manufacturer Phone | 7277246659 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENVISTA TORIC INTRAOCULAR LENS |
| Generic Name | LENS, INTRAOCULAR, TORIC OPTICS |
| Product Code | MJP |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-02-08 |
| Model Number | MX60TP |
| Catalog Number | MX60TP575+250 |
| Lot Number | 3849223 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 N. GOODMAN ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-02-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-13 |