MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-02-22 for SILIKON 1000 OIL 8065601185 manufactured by Alcon - Fort Worth / Alcon Laboratories, Inc.
[18802871]
Eval summary - no sample was provided by the customer. A review of the mfg record for this lot was requested. The supplier reviewed the batch records for lot tphw-08-04, as well as three lots produced before and afterwards. Retain samples were reviewed and verified that samples do not appear emulsified. No root cause could be determined. There have been no other complaints reported in the lot number. Add'l info has been requested. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[18981319]
A surgeon reported severe emulsification of this product by ten weeks following its use during a pars plana vitrectomy procedure. The surgeon reported two pts were affected. He also reported the product (oil) was removed but because of the emulsification, the eye still has some oil and there is anterior chamber and vitreous cellular reaction. In a f/u, the surgeon reported that for this pt, the retina is flat but there is emulsified oil on the retina and there are cells ++ in the anterior chamber and vitreous cells ++. He reported posterior capsule opacification (pco) is developing. Add'l info has been requested. There are two medical device reports associated with this event. This report is for the second pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2012-00029 |
| MDR Report Key | 2468839 |
| Report Source | 01,05 |
| Date Received | 2012-02-22 |
| Date of Report | 2012-01-24 |
| Date of Event | 2011-12-01 |
| Date Mfgr Received | 2012-01-24 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2012-02-28 |
| 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 | SILIKON 1000 OIL |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2012-02-22 |
| Model Number | NA |
| Catalog Number | 8065601185 |
| Lot Number | TPHW-08-04 |
| ID Number | NA |
| Device Expiration Date | 2012-09-30 |
| 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 | 2012-02-22 |