MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-16 for BAUSCH + LOMB manufactured by Bausch + Lomb.
[102851732]
After using this product for a few days, i became dizzy and was unable to get up or walk without assistance because i felt as if the room was rotating. Dose or amount: 3 drops for each cleaning. Frequency: twice daily. Dates of use: (b)(6) 2018. Diagnosis or reason for use: clean/disinfect contacts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075928 |
| MDR Report Key | 7348128 |
| Date Received | 2018-03-16 |
| Date of Report | 2018-03-07 |
| Date of Event | 2018-02-05 |
| Date Added to Maude | 2018-03-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAUSCH + LOMB |
| Generic Name | BIOTRUE CONTACT LEN SOLUTION |
| Product Code | LYL |
| Date Received | 2018-03-16 |
| Returned To Mfg | 2018-03-07 |
| Lot Number | GJ17017 |
| Device Expiration Date | 2019-01-09 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-16 |