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 2020-01-31 for CRYSTALENS ACCOMMODATING IOL AO1UV AO1UV-2250 manufactured by Bausch + Lomb.
[177267363]
The reporter has indicated the lens is not available for return as it remains implanted. Additional information has been requested, but has not been received. The investigation is in progress. A follow-up report will be submitted as additional information is received.
Patient Sequence No: 1, Text Type: N, H10
[177267364]
A surgeon reported that a patient underwent a yytrium aluminum garnet (yag) laser treatment for z syndrome of the intraocular lens (iol). The treatment was not effective in resolving the patient? S z syndrome. The surgeon is considering performing another yag treatment on the lens three months after the initial yag. The surgeon does not plan to remove the lens. Additional information has been requested, but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00017 |
| MDR Report Key | 9653694 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-10-29 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-01-31 |
| 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 | 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 | 2020-01-31 |
| Model Number | AO1UV |
| Catalog Number | AO1UV-2250 |
| Lot Number | 7654514 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-31 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-31 |