MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2018-12-19 for CURVED MEMBRANE SCRAPER 338.25P manufactured by Alcon Grieshaber Ag.
[130883358]
No sample has been received by manufacturing for evaluation in regards to this literature report. The affected lot is number not known therefore, the device history record could not be reviewed. A 100% final inspection is performed for this product. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. No additional information is anticipated for this literature report. (b)(4) - [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[130883359]
A physician reported that a 25ga membrane scraper was used during a combination cataract and vitrectomy procedure. The patient presented postoperatively with retinal nerve fiber layer damage and paracentral scotoma that resolved at three months postop with bcva of 20/20.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2018-00041 |
| MDR Report Key | 8179139 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date Mfgr Received | 2018-12-04 |
| Date Added to Maude | 2018-12-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | ALCON GRIESHABER AG |
| Manufacturer Street | WINKELRIEDSTRASSE 52 |
| Manufacturer City | SCHAFFHAUSEN 8203 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURVED MEMBRANE SCRAPER |
| Generic Name | SPATULA, OPHTHALMIC |
| Product Code | HND |
| Date Received | 2018-12-19 |
| Model Number | NA |
| Catalog Number | 338.25P |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON GRIESHABER AG |
| Manufacturer Address | WINKELRIEDSTRASSE 52 SCHAFFHAUSEN 8203 SZ 8203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 25 | 1. Other | 2018-12-19 |