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 2020-03-20 for CRYSTALENS ACCOMMODATING IOL AO2UV AO2UV-2050 manufactured by Bausch + Lomb.
[184826828]
The product evaluation was completed. One opened lens box was returned missing the peel pouch and directions for use (dfu). The lens was in the carrier, positioned incorrectly. Particulates, saline dendrites and dried solutions were visible on the optic. Visual inspection found the lens was in three pieces. The optic had been cut or torn in half. One plate was torn off and was lying loose in the carrier. One haptic arm on the torn off plate was bent. The cause of the damage cannot be determined. Functional testing cannot be performed due to the damage. The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates. A definitive root cause cannot be determined. The most probable root cause is operational context. User related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event. No corrective action is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
[184826829]
It was reported that during insertion of an intraocular lens (iol) into the right eye it was noticed that the haptic was torn. The iol was removed with lens forceps. There was no incision enlargement and no sutures were required. The patient had a vitrectomy and had a different lens implanted. Though requested, no additional information has been received. The reason for vitrectomy was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00057 |
| MDR Report Key | 9860764 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-02-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-20 |
| 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 | CRYSTALENS ACCOMMODATING IOL |
| Generic Name | LENS, INTRAOCULAR, ACCOMMODATIVE |
| Product Code | NAA |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-11 |
| Model Number | AO2UV |
| Catalog Number | AO2UV-2050 |
| Lot Number | 6872410 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |