MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2016-11-23 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb Incorporated.
[60815115]
The product is not available for return and the lot number was not reported. Doctor indicated the irritation for the left eye is possibly due to his contact lens. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[60815116]
Consumer reported that about 2-3 years ago his contact lens tore in his eye causing corneal bruises, abrasions and a lump to develop on his left eye. Consumer reports the doctor informed him by using the lenses in conjunction with the solution caused a layer of skin on his eye to burn off. Consumer indicated he has permanent skin loss and permanent scratches on his eye which makes him not able to wear contacts again. He also experiences burning when he cries. Consumer states he visited 3 specialists for the event. He states one of the specialists created a milky drop for him to use for 6 months as treatment to help the skin on his eye regrow. Consumer reported still having issues with his eyes and that he is using a gel and drops. Medical documentation received from the treating doctor indicated patient had complaints of burning, dryness, irritation and decreased vision. He was diagnosed with keratoconjunctivitis sicca. Temporary punctal plugs were placed bilaterally as a precautionary measure but was not required for treatment. Doctor indicated the irritation for the left eye is possibly due to his contact lens. The doctor's office confirmed that there was no penetration of bowman? S membrane, no scar, and no permanent decrease in visual acuity. Patient was last seen two years ago. Consumer has not returned to a health care provider at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2016-00667 |
| MDR Report Key | 6125192 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2016-11-23 |
| Date of Report | 2016-10-05 |
| Date of Event | 2014-04-13 |
| Date Mfgr Received | 2016-10-05 |
| Date Added to Maude | 2016-11-23 |
| 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. 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 | 2016-11-23 |
| 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 | 2016-11-23 |