MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-07-04 for MORIA ONE USE MICROKERATOME 19155 [TURBINE] manufactured by Moria, S.a., C.e..
[1270723]
In 2009, moria received notice of five cases of dlk in pts who had been operated on using a one use microkeratome. The turbine involved with the surgeries carries a unique serial number, and the one use heads were all from lot 840418. Of the five pts who underwent surgery and suffered complications, two are reportedly "not doing well", and one is non-functioning out of one eye. Moria was notified that one pt was non-functioning out of one eye in 2009. Pts whose surgeries involved other one use turbines and heads suffered no such ill effects.
Patient Sequence No: 1, Text Type: D, B5
[8435149]
The facility returned to moria its one use turbine and hose for evaluation, as well two used disposable heads and two unopened disposable heads (all heads were from lot 840418). The products were received by moria on 04/15/2009, and on 04/16/2009, moria sent a loaner turbine, a new hose, and ten disposable heads to the facility for us in future surgeries. Moria's inspection of the returned equipment reveals that there was moderate to heavy debris caused by oxidation in the internal, threaded collar of the turbine. Photos are attached at tab b. In addition, the hose was in need of a general cleaning. No problems were found with the disposable heads. Moria recommends that such turbines be serviced annually. See part two of the instruction manual, attached at tab c. While it was clear that both the turbine and hose were in need of routine maintenance, there are multiple possible causes of dlk, and moria cannot determine the actual cause of dlk for any of the five pts who experienced the complication. Moria has concluded that the problem with oxidation on the turbine's threaded collar, and with facility experience with the product, are isolated incidents that do not present quality control issues. The facility has only had issues with the turbine/head combination used in the five incidents, and moria's internal evaluation found no issues with turbines with other serial numbers, with unopened disposable heads from the same lot number, or with disposable heads from other lot numbers. Furthermore, the facility apparently did not have any suboptimal outcomes from surgeries performed with the loaner equipment it received from moria on 04/16/2009. See scanned pages.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2529598-2009-00001 |
| MDR Report Key | 1413319 |
| Report Source | 05,06 |
| Date Received | 2009-07-04 |
| Date of Report | 2009-06-03 |
| Date of Event | 2009-04-06 |
| Date Mfgr Received | 2009-04-15 |
| Device Manufacturer Date | 2000-05-01 |
| Date Added to Maude | 2009-08-03 |
| 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 Street | 1050 CROSS KEYS DR |
| Manufacturer City | DOYLESTOWN PA 18902 |
| Manufacturer Country | US |
| Manufacturer Postal | 18902 |
| Manufacturer Phone | 2152307662 |
| Manufacturer G1 | MORIA, S.A., C.E. |
| Manufacturer Street | #45P. L.P. EVOLIC 1 |
| Manufacturer City | ANTONY, CEDEX 921B2 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 921B2 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MORIA ONE USE MICROKERATOME |
| Generic Name | NONE |
| Product Code | HMY |
| Date Received | 2009-07-04 |
| Returned To Mfg | 2009-04-15 |
| Model Number | 19155 [TURBINE] |
| Catalog Number | 19155 [TURBINE] |
| Lot Number | 840418 [DISP.HEAD] |
| ID Number | 19320/130 [DISPHEAD] |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORIA, S.A., C.E. |
| Manufacturer Address | # 45P. L.P. EVOLIC 1 ANTONY, CEDEX 921B2 FR 921B2 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-04 |