MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-03-27 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb Incorporated.
[71208161]
The complaint sample was not returned for evaluation and the lot number is unknown. Additional event details are not available given that the consumer declined to disclose his contact information. It is possible that repeated unsuccessful attempts to insert the lens may have resulted in trauma to the consumer? S ocular surface. Addition of a solution to a traumatized eye can result in a burning sensation. Nevertheless, based on available information, no causal factors can be determined and no conclusions can be drawn. Consumer lists the following concomitant products on the medwatch: "methadone 10x3, metoprolol 50x2, omeprazole 20 mgs 1hs, simvastatin 40 1hs, xanax 1mgx2, valium 1hs, saw palmetto 6 capsules, multivitman, b 12 500mcg".
Patient Sequence No: 1, Text Type: N, H10
[71208162]
Medwatch report received from fda, mw5068141. Consumer reported first starting use of the product in 2013. The event date reported by the consumer (b)(6) 2014 and the report to medwatch was 23-feb-2017. Consumer reported that he had many unsuccessful attempts at inserting his lenses and was instructed by his spouse to use a drop of the product to facilitate insertion. With the drop, the lens was applied to the left eye and the consumer reported that he experienced intense burning. The consumer reported that he saw a doctor for evaluation and recalled that the doctor stated that, "the skin was burnt off my eyes. " the consumer also recalled that the doctor gave him drops (unspecified) that he had in his office and gave him an rx for an antibiotic, "to ease the infection. " consumer remarked,? To this day, the skin is still off my eyes and nothing can be done.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2017-02346 |
| MDR Report Key | 6436121 |
| Report Source | OTHER |
| Date Received | 2017-03-27 |
| Date of Report | 2017-03-13 |
| Date of Event | 2014-04-04 |
| Date Mfgr Received | 2017-03-13 |
| Date Added to Maude | 2017-03-27 |
| 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. SHARON SPENCER |
| Manufacturer Street | 50 TECHNOLOGY DRIVE WEST |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9493985698 |
| 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 | BIOTRUE MULTI-PURPOSE SOLUTION |
| Generic Name | ACCESSORIES, SOLUTION, CLEANERS FOR LENSES |
| Product Code | LYL |
| Date Received | 2017-03-27 |
| ID Number | NI |
| Device Expiration Date | 2014-04-14 |
| 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. Other | 2017-03-27 |