MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-06-15 for OPTI-FREE PUREMOIST REWETTING DROPS 00650192 manufactured by Alcon - Forth Worth Aspex/alcon Laboratories, Inc..
[2725606]
A consumer reported that she experienced "pockets of infection" following the use of this product. Additional information was received from the consumer, who reported her eyes were feeling funny so she discontinued contact lens wear. She stated when she returned to wearing her contact lenses the next day her eyes were extremely sensitive to light. She called her family doctor who told her she had an eye allergy and prescribed her antihistamine eye drop. After a week her eyes were not better and her "eye sight was starting to get weaker" in the left eye. She returned to her family doctor who diagnosed her with a sinus infection and prescribed and oral antibiotic. After ten days her eye sight was worse than before and she made an appointment with an eye doctor. The eye doctor prescribed her an ophthalmic antibiotic. In the meantime she could not stand any light or sun and her vision was "way off" in the left eye. She returned to the eye doctor with no change to her symptoms and was referred to another eye doctor. She reported this eye doctor diagnosed her with keratitis and prescribed her an antibiotic/corticosteroid ophthalmic drop. Once she started using this medication her eyes instantly started feeling better. Her eyes are now clear and her left eye vision loss is healing. There are two medical device reports associated with this event. This report is for the second product.
Patient Sequence No: 1, Text Type: D, B5
[10060695]
Evaluation summary: product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation. No root cause could be determined. Additional information was requested on (b)(4) 2012, by phone, fax, and mail. A completed questionnaire was received from the consumer on (b)(4) 2012. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2012-00082 |
| MDR Report Key | 2624386 |
| Report Source | 04 |
| Date Received | 2012-06-15 |
| Date of Report | 2012-05-14 |
| Date of Event | 2012-04-10 |
| Date Mfgr Received | 2012-05-14 |
| Date Added to Maude | 2012-06-22 |
| 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 | PAUL NITSCHMANN |
| Manufacturer Street | 6201 SOUTH FREEWAY, R3-16 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152440 |
| Manufacturer G1 | ALCON - FORTH 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 PUREMOIST REWETTING DROPS |
| Generic Name | ACCESSORIES, SOFT LENS PRODUCTS |
| Product Code | MRC |
| Date Received | 2012-06-15 |
| Model Number | NA |
| Catalog Number | 00650192 |
| Lot Number | UNK |
| 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 - FORTH 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 | 2012-06-15 |