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 2020-03-13 for CRYSTALENS ACCOMMODATING IOL AT50AO AT50AO2100 manufactured by Bausch + Lomb.
[183918450]
According to the reporter, the lens is not available for evaluation. The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates. No similar complaints have been received for this lot number. Subsequent to the reported event, the replacement iol dislocated and had to be repositioned. In the surgeon? S opinion, the likely cause of lens dislocation of the replacement lens is weak zonules. This secondary event has been deemed unrelated to the second intraocular lens implanted. As the date of diagnosis of weak zonules is unknown it cannot be conclusively determined if the z-syndrome experienced with the reported lens is also related to the weak zonules. The most probable root cause is that this event is related to the patient? S ocular anatomy. No corrective action is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
[183918451]
It was reported that a patient experienced z-syndrome of the intraocular lens (iol) implanted in the left eye. The lens was explanted and replaced with a lens of a different model. Though requested, no additional information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00053 |
| MDR Report Key | 9830291 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2014-01-01 |
| 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 | 2020-03-13 |
| 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 |
| 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 | 2020-03-13 |
| Model Number | AT50AO |
| Catalog Number | AT50AO2100 |
| Lot Number | 019978 |
| Device Expiration Date | 2016-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |