MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-07 for MORIA ONE USE PLUS MICROKERATOME 19345 (MOTOR) manufactured by Moria S.a..
[3064701]
The patient underwent lasik surgery on his right eye on (b)(6) 2010. Lasik surgery involves different components, including a microkeratome, which is a surgical instrument that cuts the flap in the cornea during the surgery. We believe moria's one use plus microkeratome system, consisting of an evolution 3e microkeratome control unit, a one use plus handpiece, sterile aspiration tubing, and a one use plus head and ring, was used in the procedure in question. The surgery resulted in a free (rather than hinged) flap. This is know complication of lasik surgery. The surgeon replaced the free flap and discontinued surgery on the right eye. A lasik procedure was completed on the left eye during the same session, without incident. The patient subsequently complained of blurred vision in the right eye. He eventually underwent a photorefractive keratectomy (prk) procedure, which reportedly corrected the blurred vision.
Patient Sequence No: 1, Text Type: D, B5
[10449799]
Moria first learned of this incident on (b)(6) 2012, and only learned that the patient alleged an injury that required medical follow-up on (b)(6) 2012. (b)(6) eye center, the facility where the surgery was performed, bought the device from moria in (b)(4) 2006. Moria's records indicate the device was last serviced in (b)(4) 2008. The device has not been serviced by moria since then, despite sending reminders to (b)(6) eye center in (b)(4) 2009 and late 2010/ early 2011 regarding the need for servicing of the device. This is an isolated incident. Moria's investigation concludes that the incident was not caused by any malfunction or defect in the microkeratome control unit or motor. As moria does not believe tha the incident was caused or contributed to by the device, this report is submitted out of an abundance of caution and only because the patient alleged a serious injury that apparently required a corrective procedure to prevent permanent impairment of his vision.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615659-2013-00001 |
| MDR Report Key | 2906344 |
| Report Source | 05,06 |
| Date Received | 2013-01-07 |
| Date of Event | 2010-09-16 |
| Date Mfgr Received | 2012-12-06 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2013-01-11 |
| 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. |
| Manufacturer Street | C.E. # 45P. L.P. EVOLIC 1 |
| Manufacturer City | ANTONY, CEDEX 921B2 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 921B2 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MORIA ONE USE PLUS MICROKERATOME |
| Generic Name | KERATOME |
| Product Code | HMY |
| Date Received | 2013-01-07 |
| Model Number | 19345 (MOTOR) |
| Catalog Number | 19345 (MOTOR) |
| Lot 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 | MORIA S.A. |
| Manufacturer Address | ANTONY FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-01-07 |