MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-10-18 for TERRY-SCHANZLIN ASTIGMATOME 04905 manufactured by Oasis Medical.
[689677]
A patient who, according to the astigmatome nomagram, required two 45 degree arcuate incisions using the 8 mm optical zone. Pre-op corneal topography showed central pachymetry of about 550 microns and mid-peripheral corneal thicknesses of 580+ microns, so a 550 micron double blade was chosen. The astigmatome was employed in the usual fashion at the beginning of the case prior to the performance of the phako/iol portion of the procedure using a rezoom lens, and resulting in two full-thickness 45 degree incisions. Each incision required suturing with a figure-eight 10-0 nylon suture.
Patient Sequence No: 1, Text Type: D, B5
[8011077]
Oasis medical is communicating with the customer to have the customer return the product in question, and oasis medical will evaluate and submit a evaluation summary when it is available. As of the date of this initial mdr, the product has not veen received. Various communications with the customer have not been able to obtain the lot number or detailed description of follow-up events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2083373-2007-00006 |
| MDR Report Key | 929670 |
| Report Source | 04 |
| Date Received | 2007-10-18 |
| Date of Report | 2007-10-18 |
| Date Mfgr Received | 2007-05-16 |
| Date Added to Maude | 2007-12-11 |
| 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 Contact | ROBYN SCOPIS, MANAGER |
| Manufacturer Street | 514 S. VERMONT AVE. |
| Manufacturer City | GLENDORA CA 91741 |
| Manufacturer Postal | 91741 |
| Manufacturer Phone | 6268525156 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERRY-SCHANZLIN ASTIGMATOME |
| Generic Name | ASTIGMATOME INSTRUMENT SET |
| Product Code | HNC |
| Date Received | 2007-10-18 |
| Model Number | 04905 |
| Catalog Number | 04905 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 924707 |
| Manufacturer | OASIS MEDICAL |
| Manufacturer Address | 514 S. VERMONT AVE. GLENDORA CA 91741 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-10-18 |