MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-17 for OPTI-FREE REPLENISH REWETTING DROPS 00650192 manufactured by Alcon-fort Worth Aspex/alcon Laboratories, Inc..
[1766582]
A consumer reported she only uses the product in her right eye and she began experiencing irritation following the use of the product. She stated she went to the doctor who did not diagnose or treat her with any medications. She noted her symptoms continued and she went back to the doctor. She stated her doctor diagnosed her with optic neuritis in the od and treated her with a high dose of corticosteroids. She noted she discontinued use of the product and she feels a little bit better. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[8877826]
Review of chemistry and micro data found that this lot met release requirements. No sample has been returned at this time for further investigation. No similar complaints have been reported for this lot. This lot has been previously tested and all results met specification. No root cause could be determined. Additional information was requested via mail on 12/01/2010; and via phone on 12/14/2010. At this time, additional information has not been received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2010-00155 |
| MDR Report Key | 1936630 |
| Report Source | 05 |
| Date Received | 2010-12-17 |
| Date of Report | 2010-12-01 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2010-12-01 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2010-12-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES DOLBEE |
| Manufacturer Street | 6201 SOUTH FREEWAY, R7-18 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175518317 |
| Manufacturer G1 | ALCON-FORT WORTH ASPEX/ALCON LABORATORIES, INC. |
| 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 REWETTING DROPS |
| Generic Name | LENS CARE DISINFECTING SOLUTIONS |
| Product Code | MRC |
| Date Received | 2010-12-17 |
| Model Number | NA |
| Catalog Number | 00650192 |
| Lot Number | 180432F |
| ID Number | NA |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON-FORT WORTH ASPEX/ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-12-17 |