MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-15 for SILIKON 1000 OIL 8065601185 manufactured by Primapharm, Inc..
[6049523]
A doctor reports that a patient is experiencing reduced central vision after ophthalmic oil was used during their procedure. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[14209100]
No sample or lot number information was received by manufacturing for evaluation. Intra-lot complaint history review was performed due to no lot code or sample received. There have been no similar issues reported in the past year. No further evaluation or root cause analysis can be conducted at this time. No root cause could be determined. Additional information has been requested, but none has been received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2015-00520 |
| MDR Report Key | 4916179 |
| Report Source | 05 |
| Date Received | 2015-07-15 |
| Date of Report | 2015-07-15 |
| Date Mfgr Received | 2015-06-19 |
| Date Added to Maude | 2015-07-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. EDDIE DARTON, MD, JD |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | PRIMAPHARM, INC. |
| Manufacturer Street | 3443 TRIPP COURT |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILIKON 1000 OIL |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2015-07-15 |
| Model Number | NA |
| Catalog Number | 8065601185 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRIMAPHARM, INC. |
| Manufacturer Address | 3443 TRIPP COURT SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-15 |