MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,05 report with the FDA on 2014-08-19 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[4904797]
Consumer used multi-purpose solution and within 2 hours experienced blurry vision and red, burning eyes. Consumer visited ophthalmologist and was diagnosed with corneal edema and treated with zylet. Later that evening, consumer felt pain in her eye and visited emergency room where she was diagnosed and treated for a corneal abrasion. The consumer followed-up with the initial ophthalmologist the next day with complaints of pain and discomfort. Upon examination, the ophthalmologist observed swelling of the right eyelid and a 1. 5mm triangular-shaped paracentral epithelial defect along with corneal staining. Corneal edema was also noted in left eye and superficial punctate keratitis. The ophthalmologist referred the consumer to a corneal specialist the same day. Per the consumer, the corneal specialist informed her that it could be shingles of the eye. A follow up was made to the consumer who confirmed her condition resolved with treatment. We are awaiting medical documentation from the emergency room and corneal specialist for this event.
Patient Sequence No: 1, Text Type: D, B5
[12185677]
Complaint sample was returned for eval, however, the sample was insufficient to perform all required testing. Results of the testing performed found the solution was within specifications. A review of the lot batch records and chemical testing of the retain sample showed all requirements were met. Based on all info, no casual factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2014-00010 |
| MDR Report Key | 4039976 |
| Report Source | 00,04,05 |
| Date Received | 2014-08-19 |
| Date of Report | 2014-07-22 |
| Date of Event | 2014-05-22 |
| Date Mfgr Received | 2014-07-22 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-08-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1400 NORTH GOODMAN ST. |
| 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 | BIOTRUE MULTI-PURPOSE SOLUTION |
| Generic Name | CONTACT LENS MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2014-08-19 |
| Returned To Mfg | 2014-07-31 |
| Lot Number | GB14106 |
| Device Expiration Date | 2016-02-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-19 |