MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for CRYSTALENS ACCOMMODATING IOL AO1UV AO1UV2250 manufactured by Bausch + Lomb.
[138081350]
The lens was not available for return. A device history record (dhr) review was performed and did not find any nonconformities or anomalies related to this complaint. A root cause for the reported event could not be conclusively determined. A medical review of this event however, attributes the issue to capsular contraction.
Patient Sequence No: 1, Text Type: N, H10
[138081351]
It was reported that a patient with bilateral crystalens implants experienced capsular contraction in both eyes, causing the implanted lenses to tilt and impairing the patient? S vision. Prior to the onset of the capsular contraction, the patient had also experienced posterior capsular fibrosis (pcf), for which she underwent yag procedures on both eyes (twice on the right eye and once on the left eye) approximately one month post-implant surgery. Regarding secondary intervention for the tilted lenses, the patient underwent two additional yag procedures on both eyes at the 3 and 4 month post-op marks. Additionally, the patient underwent photorefractive keratectomy (prk) at the 5 month post-op mark to address the astigmatism induced by the tilted lenses. At the 1 year post-op mark, the lens in the left eye was finally explanted and replaced with one of a different model. The lens on the right eye remains implanted at this time. Per the surgeon, the noted pcf was highly unusual and the patient did not have any pre-existing ocular conditions. The patient? S prognosis is reportedly fair. The visual acuity on the left eye has improved. The lens in the right eye continues to be observed at this point. This report is for the right eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2019-00044 |
| MDR Report Key | 8397103 |
| Date Received | 2019-03-06 |
| Date of Report | 2019-02-05 |
| Date of Event | 2018-04-11 |
| Date Added to Maude | 2019-03-06 |
| 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 |
| 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 | 2019-03-06 |
| Model Number | AO1UV |
| Catalog Number | AO1UV2250 |
| Lot Number | 7570114 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-06 |