MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-02-14 for BOSTON SIMPLUS MULTI-ACTION SOLUTION manufactured by Bausch & Lomb Incorporated.
[136127918]
Neither consumer contact information nor additional event details are available to the manufacturer. The complaint sample was not returned for evaluation and lot information is unknown. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[136127919]
The manufacturer obtained the following information on monday, february 4th, 2019 while conducting a search of the (b)(6) database: in 2009, a consumer reported to (b)(6) that they experienced altered visual depth perception, application site vesicles, corneal disorder, impaired driving ability, impaired work ability, vision blurred, and visual impairment after using the complaint product. No treatment information was provided. At the time of the consumer? S reporting they indicated that they had not recovered and that the incident resulted in an unspecified disability. Current outcome is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2019-00035 |
| MDR Report Key | 8339036 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-04 |
| Date Added to Maude | 2019-02-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON SIMPLUS MULTI-ACTION SOLUTION |
| Generic Name | PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE |
| Product Code | MRC |
| Date Received | 2019-02-14 |
| 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. Deathisabilit | 2019-02-14 |