MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-30 for CRYSTALENS ACCOMMODATING IOL AT50AO AT50AO-2250 manufactured by Bausch + Lomb.
[128958523]
The device was returned for evaluation. Visual inspection found that the lens is in two pieces. The optic was cut or torn in half. One haptic plate with arms was attached to each side of the returned optic. A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint. Based on the available information, a root cause for the reported event could not be determined. This report is for the second explanted crystalens iol described in the event narrative. A report for the first explanted crystalens iol was also submitted under report number 0001313525-2018-00147.
Patient Sequence No: 1, Text Type: N, H10
[128958524]
It was stated that a crystalens intraocular lens (iol), which was implanted in the right eye, was used as a replacement to another manufacturer's lens. With the other manufacturer's lens, the patient was said to have experienced halos and glare. Nearly 3 months post-implant of the crystalens iol, the patient was reported to have experienced z-syndrome. Following the explant of crystalens iol (serial number ending in (b)(4)), the patient experienced z-syndrome once more with a second crystalens iol (serial number ending in (b)(4)) after just one week. As a result, crystalens iol (serial number ending in (b)(4)) was also explanted and replaced with a lens of a different model. The surgeon attributed the recurring z-syndrome to capsular contraction. Regarding prognosis, the patient is said to be happy and seeing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2018-00222 |
| MDR Report Key | 8121477 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-30 |
| Date of Report | 2018-07-02 |
| Device Manufacturer Date | 2015-08-19 |
| Date Added to Maude | 2018-11-30 |
| 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 STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 21 NORTH PARK PLACE BLVD. |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33759 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYSTALENS ACCOMMODATING IOL |
| Generic Name | LENS, INTRAOCULAR, ACCOMMODATIVE |
| Product Code | NAA |
| Date Received | 2018-11-30 |
| Returned To Mfg | 2018-11-12 |
| Model Number | AT50AO |
| Catalog Number | AT50AO-2250 |
| Lot Number | 7560508 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-30 |