MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION manufactured by Bausch & Lomb Incorporated.
[183916240]
Product and lot number were not available. Follow up with the treating doctor indicated they have no record of the consumer using the product. Renu with moistureloc multi-purpose solution was recalled from the global market on may 15, 2006. At that same time, the company discontinued the worldwide sales and distribution of the device. Also, the premarket notifications (k033854 and k051755) for the device were withdrawn by bausch + lomb.
Patient Sequence No: 1, Text Type: N, H10
[183916241]
A consumer reported about fifteen years ago, after using the product, they experienced burning eyes, headaches, light sensitivity and they could barely open their eyes. They visited their eye doctor and was diagnosed with bilateral eye infection and retina scarring in their left eye. They reported after being prescribed an unknown antibiotic and lasik surgery, they have almost fully recovered as the scarring is healing. Follow up with the treating doctor indicates they have no record of the patient using the complaint product. They visited the office with left eye pain, stinging, foreign body sensation and light sensitivity. Their eyesight remained 20/20 with contact lenses. They were diagnosed with left eye focal keratitis, superficial punctate keratopathy and left faint central corneal scar. They were treated with acular ls. The doctor indicates they do not wish to provide additional medical information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00035 |
| MDR Report Key | 9721556 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-21 |
| Date of Event | 2005-11-01 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-18 |
| 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. JENNIFER GAMET |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853386853 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 8507 PELHAM ROAD |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Removal Correction Number | Z-1201-06 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION |
| Generic Name | ACCESSORIES, SOFT LENS PRODUCTS |
| Product Code | LPN |
| Date Received | 2020-02-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB INCORPORATED |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-02-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-18 |