MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-12-02 for PERFLUORON 8065900113 manufactured by Alcon Laboratories, Inc..
[61347036]
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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[61347037]
A literature report indicated that while removing perfluorocarbon (pcfl) during the repair of a retinal detachment surgery, the patient experienced a macular hole. Pcfl moved into the subretinal retinal space of the macular hole. The patient had an additional procedure to repair the macular hole.
Patient Sequence No: 1, Text Type: D, B5
[66698659]
No sample or lot code was returned by this customer; therefore, lot specific evaluation cannot be completed, at this time. The suspected product is contraindicated for long-term use in the eye or as a vitreous replacement. The suspected product must be completely removed at the conclusion of the procedure by aspiration through either a 23 gauge or flute needle during the air-fluid exchange, or by direct exchange with an appropriate long-term vitreous substitute. Root cause could not be determined, however potential root causes include:? Product nonconformance; this is unlikely based on the compounding and filling procedures and controls that are in place. ? Events outside of manufacturer (e. G. Product use, storage conditions, etc. ); however, this cannot be confirmed. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2016-00124 |
| MDR Report Key | 6142214 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-02 |
| Date of Report | 2017-02-07 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2017-01-30 |
| Date Added to Maude | 2016-12-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| 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 | PERFLUORON |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2016-12-02 |
| Model Number | NA |
| Catalog Number | 8065900113 |
| Lot Number | ASKU |
| 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 LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-02 |