MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-09-02 for SILIKON 1000 OIL 8065601185 manufactured by Alcon - Fort Worth / Alcon Labs Inc..
[20745820]
Adverse event(s): "no harm" (no consequences or impact to pt). Product problem(s): "milky whitish" (no code available); "too hard to be injected" (physical resistance). A surgeon reported that when the surgeon tried to inject the product, "it was too hard to be injected and exchanged the product to water". When the residue product was exchanged to water, the product turned milky/whitish. The surgeon removed the product from the eye, and instead used a competitor's product. There was no harm to the pt. No further info is expected.
Patient Sequence No: 1, Text Type: D, B5
[20824653]
The product was returned for analysis and was verified to have signs of mis-handling. The product has been subjected to a secondary sterilization cycle by the end user. Directions for use in the product insert state that re-sterilization of the product is not to be performed. While we were unable to determine the origin of the damage, our observations reasonably suggest the damage is not mfg related. There have been no other complaints reported in the lot number. No further info is expected. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2010-00113 |
| MDR Report Key | 1854135 |
| Report Source | 01,05 |
| Date Received | 2010-09-02 |
| Date of Report | 2010-08-03 |
| Date of Event | 2010-08-03 |
| Date Mfgr Received | 2010-08-03 |
| 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 | CHARLES DOLBEE |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175518317 |
| Manufacturer G1 | ALCON - FORT WORTH / ALCON LABS INC |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76134 |
| Single Use | 3 |
| 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 | 2010-09-02 |
| Returned To Mfg | 2010-08-24 |
| Model Number | NA |
| Catalog Number | 8065601185 |
| Lot Number | TPHU-09-03 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON - FORT WORTH / ALCON LABS INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-02 |