MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-19 for OPTI-FREE GP 00650288 manufactured by Alcon - Fort Worth/alcon Laboratories, Inc..
[1344210]
Adverse event(s): "burn" (burning sensation); "red eyes" (red eye(s)); "pain" (pain); "central keratitis and chemical keratitis" (keratitis). Product problem(s): "none reported" (no info). A technician reported, a pt experienced a chemical burn in both eyes following the use of the product. She stated, the pt inserted her lenses in her eyes and she proceeded to take her acuity. She reported the pt immediately began to cry and her eyes turned red. She noted, the pt removed her lenses and cleaned them again with the solution and she had the same reaction. On 06/07/2010, additional info was received from the optometrist. He stated, he examined the pt prior to the consumer putting on her lenses and her cornea was clear. He reported following the consumer's reaction he examined her cornea and she had central keratitis that he diagnosed as chemical keratitis. He noted, the consumer did not have a chemical burn, but a strong burning sensation. The optometrist reported the consumer's symptoms have resolved.
Patient Sequence No: 1, Text Type: D, B5
[8616404]
Eval summary: the complaint device associated with this report was not received for eval. It is unk if the product was used according to labeled indications. Batch records were reviewed for lot 173063f and no deviations were identified. Chemistry and microbial results, environmental, utility, bioburden, and sanitization records were also reviewed and found to be acceptable. Lot 173063f met all release criteria prior to product release. There are no similar reports for this lot. Additional info was requested by phone on 05/26/2010, 06/07/2010, and 06/08/2010. Medical records were received on 06/07/2010. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2010-00062 |
| MDR Report Key | 1731648 |
| Report Source | 05 |
| Date Received | 2010-06-19 |
| Date of Report | 2010-05-25 |
| Date of Event | 2010-05-13 |
| Date Mfgr Received | 2010-05-25 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2010-06-24 |
| 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/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 GP |
| Generic Name | LENS CARE DISINFECTING SOLUTIONS |
| Product Code | MRC |
| Date Received | 2010-06-19 |
| Model Number | NA |
| Catalog Number | 00650288 |
| Lot Number | 173063F |
| ID Number | NA |
| Device Expiration Date | 2011-05-30 |
| 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 - FORT WORTH/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 | 2010-06-19 |