MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-04-25 for BIOTRUE MULTI-PURPOSE SOLUTION 70061 manufactured by Bausch & Lomb Incorporated.
[143247659]
The product has been returned and is currently being evaluated. A review of the lot batch records and testing of retain sample is in progress. Additional medical information has been requested. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[143247660]
A consumer reported to a sales rep that they woke up with eye pain and blurred vision in their left eye after wearing contact lenses and using a contact lens solution. The consumer visited their optometrist on (b)(6) 2019 and was referred to a surgery center where they were diagnosed with a corneal graze. A/b eye drops were prescribed to be used four times a day and systhane as needed. The consumer was then seen by a different doctor within the surgery center on (b)(6) 2019 and was diagnosed instead with acanthamoeba keratitis. Later that day, they visited a hospital where confocal microscopy was performed and acanthamoeba keratitis was confirmed. Polyhexanide 0. 02% and brolene drops were prescribed and the consumer was instructed to use systhane eye drops as needed. The consumer was seen for a follow up appointment on (b)(6) 2019 and was advised to continue brolene and polyhexanide. On (b)(6) 2019 the consumer had another follow up appointment where they were told to discontinue use of the brolene but to continue with the polyhexanide. The consumer was last seen by their doctor on (b)(6) 2019 where they were told to continue the polyhexanide and for pain relief were prescribed panadiene forte and nurofen plus. The consumer has future follow up appointments with the hospital doctor and the optometrist. Additional medical information has been requested but not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2019-00076 |
| MDR Report Key | 8551877 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-04-25 |
| Date of Report | 2019-10-17 |
| Date of Event | 2019-03-27 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-10-17 |
| Device Manufacturer Date | 2017-12-02 |
| Date Added to Maude | 2019-04-25 |
| 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. 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 | 0 |
| Previous Use Code | 0 |
| 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 | 2019-04-25 |
| Returned To Mfg | 2019-04-17 |
| Model Number | 70061 |
| Lot Number | GL17107 |
| Device Expiration Date | 2019-11-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-04-25 |