MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-20 for OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION 0065035720 manufactured by Alcon Research, Llc.
[175831474]
The complaint sample has not returned for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[175831475]
It was reported that the patient started the use of the complaint product on (b)(6) 2019. It was added that the patient had used other multipurpose disinfecting solutions in the past without any issues. It was mentioned that both the right (od) and left eye (os) of the patient became very red and eventually became painful. The optometrist diagnosed the patient with four corneal ulcerations in the os and was prescribed with an unknown antibiotic drops, treatment modality also unknown. It was noted that the os still stung on occasion especially if the patient's eyes were dry. Additional information has been requested but not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2020-00002 |
| MDR Report Key | 9605513 |
| Report Source | CONSUMER |
| Date Received | 2020-01-20 |
| Date of Report | 2020-02-13 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2019-05-17 |
| Date Added to Maude | 2020-01-20 |
| 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 | MR. JASON MICHAELIDES |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686438 |
| Manufacturer G1 | ALCON RESEARCH, LLC |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION |
| Generic Name | ACCESSORIES, SOFT LENS PRODUCTS |
| Product Code | LPN |
| Date Received | 2020-01-20 |
| Model Number | NA |
| Catalog Number | 0065035720 |
| Lot Number | 311693F |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-20 |