MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-18 for EASY-LOAD LENS DELIVERY SYSTEM EZ-28V manufactured by Bausch + Lomb.
[183916247]
The device was not returned for evaluation. The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates. Based on the information provided, we are unable to determine root cause. No corrective action is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
[183916248]
It was reported that during insertion of an intraocular lens (iol) into the left eye, the lens was not able to be placed due to rupture of the posterior capsule. The lens was removed with forceps and a vitrectomy was performed. The iol optic was clear and free of debris/deposits. An anterior chamber lens was successfully placed. No sutures were required as a result of the change in surgery plan. The surgeon does not know what caused the posterior capsule tear. The patient? S prognosis is good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00037 |
| MDR Report Key | 9722589 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-18 |
| Date of Report | 2019-12-18 |
| Date of Event | 2019-12-16 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | EASY-LOAD LENS DELIVERY SYSTEM |
| Generic Name | FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) |
| Product Code | MSS |
| Date Received | 2020-02-18 |
| Model Number | EZ-28V |
| Catalog Number | EZ-28V |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-02-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-18 |