MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-06-18 for OPTI-FRE SUPRACLEANS DAILY PROTEIN REMOVER 0065028503 manufactured by Alcon Laboratories, Inc., Alcon - Fort Worth Aspex.
[3141152]
Consumer report experiencing ocular pain, redness, blurred/double vision with a yellow cast to everything in her field of vision after soaking her contact lenses for more than 24 hours in this product and saline solution (not specified). She states she was diagnosed with chemical burns, abrasions, and edema or the cornea. Add'l info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[10512833]
Findings: the contact lens cleaner has not been returned to the mfr. Lot number was not provided to mfr. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2007-00015 |
| MDR Report Key | 2971241 |
| Report Source | 04 |
| Date Received | 2007-06-18 |
| Date of Report | 2007-06-14 |
| Date Mfgr Received | 2007-05-22 |
| Date Added to Maude | 2013-02-22 |
| 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 | KIM KRACKE |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8175518338 |
| Manufacturer G1 | ALCON LABORATORIES, INC, |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134209 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76134 2099 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTI-FRE SUPRACLEANS DAILY PROTEIN REMOVER |
| Generic Name | LENS CARE CLEANERS |
| Product Code | MRC |
| Date Received | 2007-06-18 |
| Model Number | NA |
| Catalog Number | 0065028503 |
| Lot Number | NI |
| ID Number | NA |
| 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 LABORATORIES, INC., ALCON - FORT WORTH ASPEX |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134209 US 76134 2099 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-18 |