MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03 report with the FDA on 2012-05-24 for SILICON 1000 OIL 8065601185 manufactured by Alcon - Fort Worth / Alcon Laboratories, Inc..
[2741891]
Through a literature abstract, a surgeon presented the case of a pt who had migration of silicon oil (so) to the lid margin following a procedure to treat a retinal detachment. The pt first presented with retinal detachment in 2006. She then had a re-detachment of the retina in (b)(6) 2008. Following the circling and so tamponade procedure, slight swelling of the lid margin was noted. One month following the surgery, the pt was treated with antibiotics due to aggravation of the lid swelling. In (b)(6) 2008, the surgeon attempted to surgically remove the so from the lid margin. The so was removed from the eye in (b)(6) 2009. During this procedure, leakage of the so from the yarn through scleral buckling was confirmed. Following this, a surgical procedure to correct ptosis was performed by a plastic surgeon because the right side of the lid margin had swelling and serious ptosis. Granulation tissue was found in the eyelid. Pathological findings confirmed findings that would be made by the so removal mark and infiltration of foam cells.
Patient Sequence No: 1, Text Type: D, B5
[9928604]
Eval summary: the complaint device was not rec'd for eval. Product history records could not be reviewed because the rptr did not provide a lot number or any identification traceable to the mfg documentation. (b)(4). A case of intraocular silicon oil strayed into upper eyelid. Presented at (b)(6). (b)(4). Conclusion: in the case of using so, we should check if there is leakage from the wound after the surgery. According to the case, there was the possibility of local serious complication caused by spreading leakage silicon oil.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2012-00070 |
| MDR Report Key | 2593313 |
| Report Source | 01,03 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-04-24 |
| Date of Event | 2008-12-01 |
| Date Mfgr Received | 2012-04-24 |
| Date Added to Maude | 2012-06-01 |
| 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 | PAUL NITSCHMANN |
| Manufacturer Street | 6201 SOUTH FREEWAY, R3-16 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152440 |
| Manufacturer G1 | ALCON - FORT WORTH / ALCON LABORATORIES, 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 | SILICON 1000 OIL |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2012-05-24 |
| Model Number | NA |
| Catalog Number | 8065601185 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON - FORT WORTH / ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-05-24 |