MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-05-25 for CLERZ PLUS LENS DROPS 00650192 manufactured by Alcon - Fort Worth Aspex / Alcon Laboratories, Inc..
[22042213]
A consumer reported that following the use of this product, he experienced his eyes becoming extremely irritated. The consumer reported at first it was a burning sensation and then it led to temporary blindness. He had his mother take him to the hospital. He reported he was told in the emergency room that he had the option of having surgery or going blind. He reported he had the procedure (unknown what type) the next morning. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[22200717]
Evaluation summary: the complaint device was not received for evaluation. Product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation. Additional information was requested on 04/27/2012 by phone, fax, and mail. A completed questionnaire has not been received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2012-00073 |
| MDR Report Key | 2593499 |
| Report Source | 04 |
| Date Received | 2012-05-25 |
| Date of Report | 2012-04-26 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2012-04-26 |
| Date Added to Maude | 2012-06-01 |
| 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 - 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 | CLERZ PLUS LENS DROPS |
| Generic Name | ACCESSORIES, SOFT LENS PRODUCTS |
| Product Code | MRC |
| Date Received | 2012-05-25 |
| Model Number | NA |
| Catalog Number | 00650192 |
| 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 - 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 | 2012-05-25 |