MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-02 for PROSHIELD 8065101701 manufactured by Alcon Laboratories, Inc., Oasis.
[587387]
A surgeon reports difficulty with the collagen corneal shield. During surgery, the shield was soaked in a topical antibiotic with a steroid, and then placed on the cornea. (the patient was being treated with a hyper osmotic treatment. ) the patient developed corneal edema which has lasted for one month. The surgeon had to physically remove the corneal shield from the patient's eye. The patient is experiencing poor vision and stated he felt like there was a foreign body in his eye. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[8056177]
Investigation including root cause determination is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2007-00010 |
| MDR Report Key | 823080 |
| Date Received | 2007-03-02 |
| Date of Report | 2007-02-02 |
| Date Mfgr Received | 2007-02-02 |
| Date Added to Maude | 2007-03-06 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL BUENGER |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8175516810 |
| Manufacturer G1 | OASIS, ALCON LABORATORIES, INC. |
| Manufacturer Street | 6201 S. FREEWAY |
| Manufacturer City | FT. 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 | PROSHIELD |
| Generic Name | COLLAGEN CORNEAL SHIELD |
| Product Code | MOE |
| Date Received | 2007-03-02 |
| Model Number | NA |
| Catalog Number | 8065101701 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 810488 |
| Manufacturer | ALCON LABORATORIES, INC., OASIS |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 761342099 US |
| Baseline Brand Name | PROSHIELD |
| Baseline Generic Name | COLLAGEN SHIELD |
| Baseline Model No | 8065101701 |
| Baseline Catalog No | 8065101701 |
| Baseline ID | NA |
| Baseline Device Family | COLLAGEN CORNEAL SHIELD |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K902558 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-02 |