MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-18 for EYE-PAK OPHTHALMIC DRAPE 8065103120 manufactured by Alcon Research, Llc - Houston.
[183917075]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183917076]
A patient reported she experienced redness and peeling of the skin around the cheek and temple area after undergoing a cataract extraction on her right eye. The patient initially indicated she used cortisone cream and the issue resolved after ten days. Additional information from the patient was received. The patient indicated the skin was removed with the drape from the cheek and temple area. She applied a triple antibiotic ointment for weeks and the area healed with no scarring or residual effects. No additional information is expected. This is one report of two for this patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644019-2020-00152 |
| MDR Report Key | 9848062 |
| Report Source | CONSUMER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-18 |
| 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 | 3 |
| Manufacturer Contact | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | ALCON RESEARCH, LLC - HOUSTON |
| Manufacturer Street | 9965 BUFFALO SPEEDWAY |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EYE-PAK OPHTHALMIC DRAPE |
| Generic Name | DRAPE, PATIENT, OPHTHALMIC |
| Product Code | HMT |
| Date Received | 2020-03-18 |
| Model Number | NA |
| Catalog Number | 8065103120 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |