MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-25 for SILIKON 1000 OIL 8065601185 manufactured by Alcon - Fort Worth / Alcon Labs, Inc..
[2339666]
A surgeon reported a pt with a history of retinal detachment procedures. During one of the procedures to treat the retinal detachment, silicone oil was placed in the anterior chamber angle covering the angle. The silicone oil remains in the anterior pole. The surgeon reported twenty-four hours following a secondary glaucoma filtration surgery, the pt had an intraocular pressure (iop) of 5 mmhg and the implant was in a good position. At forty-eight hours following the glaucoma surgery, the pt sneezed which produced a bleed with hyphema. The surgeon stated three anterior chamber washes were performed but the bleed returned. The surgeon reported location of the bleed is unk. Additional info has been requested. There are two medical device reports associated with this event. This report is for the report is for the silikon oil.
Patient Sequence No: 1, Text Type: D, B5
[9372221]
Eval summary: no lot code or sample was provided by the customer. No further eval or root cause analysis can be conducted at this time. No root cause could be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2011-00113 |
| MDR Report Key | 2314428 |
| Report Source | 05 |
| Date Received | 2011-10-25 |
| Date of Report | 2011-09-25 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2011-09-25 |
| Date Added to Maude | 2011-11-01 |
| 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 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 | 2011-10-25 |
| Model Number | NA |
| Catalog Number | 8065601185 |
| Lot Number | NI |
| 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 LABS, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-25 |