MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-02 for SILIKON 1000 OIL 8065601185 manufactured by Alcon - Fort Worth/alcon Laboratories, Inc..
[4394236]
A customer reported that a patient experienced an allergic reaction to a product. The customer is not absolutely sure it was the product that caused the reaction, but he has decided to discontinue the use of the product with the same lot on other patients. There is not additional patient or surgical information available.
Patient Sequence No: 1, Text Type: D, B5
[11893615]
No additional complaints have been received for this lot code/complaint type. The returned sample was evaluated and root cause could not be determined. All in -process testing met specifications for this lot code at the time of release. Root cause cannot be determined based on current available data. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2014-00053 |
| MDR Report Key | 3834631 |
| Report Source | 05 |
| Date Received | 2014-05-02 |
| Date of Report | 2014-04-04 |
| Date Mfgr Received | 2014-04-04 |
| Date Added to Maude | 2014-05-29 |
| 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 | JANET MORAN |
| Manufacturer Street | 6201 SOUTH FREEWAY R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152742 |
| 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 | 2014-05-02 |
| Returned To Mfg | 2014-04-24 |
| Model Number | NA |
| Catalog Number | 8065601185 |
| Lot Number | TPHY-09-01 |
| 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 LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-02 |