MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-31 for HYDROVIEW INTRAOCULAR LENS YG YG225 manufactured by Bausch + Lomb.
[186140135]
The reporter has indicated that the product is not available for analysis. As such, calcification of the lens cannot be confirmed. Based on the information provided, we are unable to determine a root cause. Our internal review did not find any anomalies that may be related to this event. The risk analysis and directions for use are considered acceptable, and the product is performing within anticipated rates. Based on the information provided, we are unable to determine a root cause. As this product has been discontinued, no corrective action is necessary.
Patient Sequence No: 1, Text Type: N, H10
[186140136]
It was reported that an intraocular lens (iol) was explanted eighteen years seven months after implant as a result of lens opacification due to presumed calcification. The lens had been implanted for a senile cataract in the right eye. The opacification was initially observed approximately nine years and three months after implantation. Reduced visibility of the fundus was observed, and opacity in which calcium deposition was suspected were observed in the product. Eighteen years and seven months post implant the lens and the capsule were removed, and a replacement intraocular lens was sewn in. The peripheral cortex fell into the vitreous body at the time of removal. Vitreous removed by surgery. One month post implant, the outcome has improved and the patient has recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00064 |
| MDR Report Key | 9904288 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-31 |
| Date of Report | 2019-09-04 |
| Date of Event | 2010-09-06 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-31 |
| 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 | HYDROVIEW INTRAOCULAR LENS |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HQL |
| Date Received | 2020-03-31 |
| Model Number | YG |
| Catalog Number | YG225 |
| Lot Number | 59MB |
| 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 | 2020-03-31 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |