MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-05 for UP & UP MULTIPURPOSE SOLUTION ADVANCED FORMULA manufactured by Bausch & Lomb, Inc..
[138087843]
I had switched contact solution and went to put my contacts in before work. My eyes starting burning to the point i was unable to open my eyes. When i finally was able to, i couldn? T see? My vision was hazy. I had chemical burns/corneal abrasions on both my eyes and both rather severe. I missed 2 days of work due to being unable to see to drive. It also caused light sensitivity. Chemical/corneal abrasions. Is the product compounded? Yes. Is the product over-the-counter? Yes. Did the problem stop after the person reduced the dose or stopped taking or using the product? Yes. Frequency, as needed. How was it taken or used. Contact set in solution then put in eye. Date the person stopped taking or using the product, (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084673 |
| MDR Report Key | 8394180 |
| Date Received | 2019-03-05 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-02-25 |
| Date Added to Maude | 2019-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | UP & UP MULTIPURPOSE SOLUTION ADVANCED FORMULA |
| Generic Name | ACCESSORIES, SOLUTION, ULTRASONIC CLEANERS FOR LENSES |
| Product Code | LPN |
| Date Received | 2019-03-05 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Brand Name | UP & UP MULTIPURPOSE SOLUTION ADVANCED FORMULA |
| Generic Name | ACCESSORIES, SOLUTION, ULTRASONIC CLEANERS FOR LENSES |
| Product Code | LYL |
| Date Received | 2019-03-05 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-05 |