MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-07-11 for PMMA POSTERIOR CHAMBER INTRAOCULAR LENS EZE-55C 7WC1950 manufactured by Bausch + Lomb.
| Report Number | 0001313525-2019-00108 |
| MDR Report Key | 8782080 |
| Report Source | FOREIGN |
| Date Received | 2019-07-11 |
| Date of Report | 2019-06-12 |
| Date of Event | 2019-05-18 |
| Date Added to Maude | 2019-07-11 |
| 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. TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN ST |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PMMA POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HDL |
| Date Received | 2019-07-11 |
| Model Number | EZE-55C |
| Catalog Number | 7WC1950 |
| Lot Number | 2841503 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN ST ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-11 |