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 2018-11-07 for PERFLUORON 8065900111 manufactured by Alcon Laboratories, Inc..
[126414865]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[126414866]
A physician reported that retinal damage was suspected after application of an ophthalmic liquid during a vitreoretinal procedure. Postoperatively, after the ophthalmic gas diffused from the eye, the patient presented with a central scotoma. Absence of the internal retinal layers was found on imaging. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[134622548]
Review of the compounding and filling manufacturing batch records (mbrs) showed no anomalies that may have contributed to the complaint condition. No nonconformance's were noted in the mbrs. Review of the incoming component inspection reports showed to be acceptable (reference the component grid for lot code). All finished product testing results met specifications. The product is manufactured according to requirements of the device master record. The product is sterilized via filtration through sterilized silastic tubing filled into dry heat sterilized vials using a peristaltic pump. All testing for the batch associated with the reported lot met specifications. Customer product storage and use could not be confirmed. Root cause could not be determined. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2018-00042 |
| MDR Report Key | 8046819 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-07 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-09-13 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2017-10-24 |
| Date Added to Maude | 2018-11-07 |
| 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. 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 | PERFLUORON |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2018-11-07 |
| Model Number | NA |
| Catalog Number | 8065900111 |
| Lot Number | 276079F |
| Device Expiration Date | 2019-10-31 |
| 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 | 2018-11-07 |