MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2012-09-07 for ALCON CONTACT LENS CASE manufactured by Alcon - Fort Worth/alcon Laboratories Inc..
[2876028]
A consumer reported that after soaking her contact in this solution using a new lens case, she experienced pain when she placed the contact lens in her right eye and when she removed the contact lens, she could not see. She went to the doctor and he put numbing solution on her eye and a dye to see what the problem was. He removed five pieces of plastic from her eye and found scratches on her cornea. The consumer indicated the contact lens case that was used came from a kit given to her at the doctor's office. The box of the kit was sealed when she received it and contained the solution and a lens case. She stated that her doctor is treating the scratches with neomycinpolymoxin ointment. Add'l info was received from the optometrist who reported the pt was diagnosed with corneal abrasions and confirmed that five conjunctival plastic foreign bodies were removed. He reported that the plastic pieces came from the lens case. He reported the event has resolved. Add'l info was received from the consumer who reported she still struggles to see clearly.
Patient Sequence No: 1, Text Type: D, B5
[10104908]
Eval summary: no sample was returned from the customer. Review of the complaint history for the lens case lots mf02007 and mf02009 showed no other complaints were reported. This lot met all release criteria prior to product release. Customer product use and lens care practice could not be confirmed. The root cause could not be determined; the particulate material observed by the customer was not received at alcon for eval. Add'l info was requested and received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2012-00114 |
| MDR Report Key | 2739341 |
| Report Source | 04,05 |
| Date Received | 2012-09-07 |
| Date of Report | 2012-08-09 |
| Date of Event | 2012-08-09 |
| Date Mfgr Received | 2012-08-09 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2012-09-12 |
| 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/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 | ALCON CONTACT LENS CASE |
| Generic Name | CONTACT LENS CASE |
| Product Code | LRX |
| Date Received | 2012-09-07 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | MF02007, MF02009 |
| 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/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 | 2012-09-07 |