MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-29 for PRE-OP TORIC REFERENCE MARKER WITH BUBBLE LEVEL AE-2791TBL manufactured by Asico Llc.
[51188169]
The toric bubble markers, used to mark eye for intra-ocular lens procedures, was not sterilized properly. Contributing factor: instructions for use for asico toric markers have conflicting information, which led to operator use error. In the ifu on page 2, general care items, it states "ultrasonically clean the markers at least once per day". This creates confusion and should be amended or removed, as the item should be cleaned and sterilized prior to each use. Footnote on the three pages of the asico toric markers instructions for use (ifu): "valid from: (b)(6) 2014; valid to: cancellation; version: 16; l-toric dfu/eng/2006".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063789 |
| MDR Report Key | 5842869 |
| Date Received | 2016-07-29 |
| Date of Report | 2016-07-29 |
| Date of Event | 2016-07-15 |
| Date Added to Maude | 2016-08-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRE-OP TORIC REFERENCE MARKER WITH BUBBLE LEVEL |
| Generic Name | TORIC MARKET |
| Product Code | HMR |
| Date Received | 2016-07-29 |
| Model Number | AE-2791TBL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASICO LLC |
| Manufacturer Address | WESTMONT IL 60559 US 60559 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-29 |