MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-03 for SILIKON 1000 OIL 8065601187 manufactured by Alcon Laboratories, Inc..
[129055918]
No sample has been received by manufacturing for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. Additional information was requested. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[129055920]
A health professional reported that ophthalmic oil was instilled into a patient's eye during a vitrectomy, scleral buckle and macular peel surgery after which the patient experienced increased inflammation, iritis and uveitis. The patient was treated with increased drops post-operatively. The patient's condition is reported as resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2018-00047 |
| MDR Report Key | 8124462 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-03 |
| Date of Report | 2019-02-15 |
| Date of Event | 2018-10-12 |
| Date Mfgr Received | 2019-02-07 |
| Device Manufacturer Date | 2018-01-22 |
| Date Added to Maude | 2018-12-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | 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 | 2018-12-03 |
| Model Number | NA |
| Catalog Number | 8065601187 |
| Lot Number | 282405F |
| Device Expiration Date | 2019-12-31 |
| 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 LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-03 |