MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-10-15 for MEDPOR OCULAR SCREW AND ACCESSORIES 89103 manufactured by Porex Surgical.
[19656484]
The ocularist stated that he saw the pt for fitting of prosthesis to the right eye using the medpor attractor coupling system on (b)(6) 2007. The ocularist took impression using the aquasil ultra l. V. The doctor stated that the position of the attractor was visible, although not clearly. The ocularist stated that he placed three magnets in the prosthesis with good results on (b)(6) 2007. The ocularist stated that the pt presented with upper-lid ptosis on (b)(6) 2007. The ocularist stated that the upper-lid ptosis was corrected by bulking up corneal area. The ocularist stated that the ptosis was due to decrease in swelling. The ocularist stated that the socket was slightly injected after removal of some of the stitches and the plastic over the magnets and the conjunctiva at the magnet site were not damaged. The ocularist reported that on (b)(6) 2008, the pt presented with exposure of 15mm. The ocularist stated that some deeper stitches were removed two weeks prior to the exposure and the doctor prescribed maxitrol and acular. The ocularist reported that he removed the magnet from the prosthesis but it resulted in inferior lateral decentration. The ocularist reported that he restarted new prosthesis. Impression taken with the aquasil ultra xlv.
Patient Sequence No: 1, Text Type: D, B5
[19751387]
The device info was not provided by the ocularist; therefore an investigation could not be conducted on the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00016 |
| MDR Report Key | 1877606 |
| Report Source | 00 |
| Date Received | 2010-10-15 |
| Date of Report | 2010-08-09 |
| Date of Event | 2008-06-11 |
| Date Mfgr Received | 2008-06-18 |
| Date Added to Maude | 2010-11-03 |
| 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 Contact | KENT IVERSEN |
| Manufacturer Street | 15 DART RD. |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| Manufacturer Phone | 6784791610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR OCULAR SCREW AND ACCESSORIES |
| Generic Name | MEDPOR OCULAR SCREW AND ACCESSORIES |
| Product Code | MQU |
| Date Received | 2010-10-15 |
| Model Number | NA |
| Catalog Number | 89103 |
| Lot Number | UNK |
| ID Number | 510K #K040851 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-15 |