MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05 report with the FDA on 2014-11-10 for RENU FRESH MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb, Inc..
[15813589]
A (b)(6) female experienced burning, pain, edema and blurred vision resulting in a visit to emergency care after use of product. According to the patient, the ophthalmologist diagnosed bilateral corneo-conjunctival burning more severe on the right eye. Ophthalmologist treated patient and administered a corticosteroid treated patient and administered a corticosteroid injection in right eye conjunctiva. Doctor informed patient that the corneal burn was a grade 3 on the right eye and grade 1 in the left eye. At follow up visit 2 days later, patient's distance corrected visual acuity in the left eye was 08/10; the right eye distance corrected visual acuity was 3/10. Patient had another f/u visit 4 days later, distance corrected visual acuity in the left eye was 08/10 and the right eye distance corrected visual acuity showed little improvement. Patient had corneal ulcers and was instructed to continue treatment for 5 weeks. Treating doctor was contacted and confirmed there was no infection, no cultures were performed. Patient's fundus examination is fine; condition has improved and a follow up visit is scheduled in one month. We are awaiting additional info from the doctor.
Patient Sequence No: 1, Text Type: D, B5
[16134786]
The complaint sample was returned for evaluation and the results of the chemical testing performed were consistent with shelf life limits. 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 | 1313525-2014-00012 |
| MDR Report Key | 4255568 |
| Report Source | 01,04,05 |
| Date Received | 2014-11-10 |
| Date of Report | 2014-10-14 |
| Date of Event | 2014-10-11 |
| Date Mfgr Received | 2014-10-14 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-11-19 |
| 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, INC. |
| Manufacturer Street | VIA PASUBIO 34 |
| Manufacturer City | MACHERIO, MILAN 20050 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 20050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENU FRESH MULTI-PURPOSE SOLUTION |
| Generic Name | CONTACT LENS MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2014-11-10 |
| Returned To Mfg | 2014-10-31 |
| Lot Number | BE096.2 |
| 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, INC. |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-10 |