MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-04-07 for EYE-PAK OPHTHALMIC DRAPE 8065103220 manufactured by Alcon Research, Ltd. - Houston.
[72083525]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[72083526]
A customer reported that a patient experienced a corneal epithelial tear when sticking down the drape. The issue caused no delay to the procedure, but postoperative discomfort and pain. The patient was treated with a steroid and an antibiotic and is recovering slowly. The sample is not available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[78487204]
The lot specific to this event is not known; therefore, lot history and device history record reviews are not possible. A sample has not been returned; therefore, the condition of the product could not be verified. The root cause of the customer's complaint is not known; a sample was not returned for investigation. Based on the information provided by the customer, the most likely root cause of this complaint is an error that occurred during the supplier's manufacturing process. Another potential root cause is the technique that is used to remove the drape. Action will not be taken for this occurrence as the root cause is not known. Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644019-2017-00326 |
| MDR Report Key | 6471440 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-07 |
| Date of Report | 2017-06-09 |
| Date of Event | 2017-02-18 |
| Date Mfgr Received | 2017-06-08 |
| Date Added to Maude | 2017-04-07 |
| 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 | MS. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - HOUSTON |
| Manufacturer Street | 9965 BUFFALO SPEEDWAY |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| Single Use | 3 |
| 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 | 2017-04-07 |
| Model Number | NA |
| Catalog Number | 8065103220 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-07 |