MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-03-02 for RENUADVANCEDFORMULAMULTI-PURPOSESOLUTION manufactured by Bausch & Lomb Incorporated.
[101375210]
The complaint sample was not returned for evaluation and the product lot number was not provided. Additional information has been requested but has not been received. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[101375231]
A consumer reported, "y'all gave me ulcers in my eye" in response to a social media advertisement for the contact lens solution. No additional information was made available regarding the specific product (lot number), circumstances, or any associated medical evaluation/treatment. Additional information has been requested but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2018-00055 |
| MDR Report Key | 7309565 |
| Report Source | CONSUMER |
| Date Received | 2018-03-02 |
| Date of Report | 2018-02-03 |
| Date Mfgr Received | 2018-02-03 |
| Date Added to Maude | 2018-03-02 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 8507 PELHAM ROAD |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENUADVANCEDFORMULAMULTI-PURPOSESOLUTION |
| Generic Name | ACCESSORIES, SOLUTION, CLEANERS FOR LENSES |
| Product Code | LYL |
| Date Received | 2018-03-02 |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB INCORPORATED |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-02 |