MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-26 for PERFLUORON manufactured by Alcon Laboratories, Inc..
[63304823]
No sample or lot number information 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 has been requested. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63304824]
A patient reported that residual ophthalmic oil was retained in their left eye post-op retinal procedure which is noticeable to the patient upon looking up. The residual oil is planned to be removed during a future cataract surgery. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[66884411]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66884412]
Additional information was received on a returned questionnaire which confirmed that surgery for the removal of ophthalmic device liquid was performed with a 27g micro-incision vitrectomy surgery (mivs) needle. Afterwards, no ophthalmic device liquid remained in the eye and the patient's postoperative was reported as good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2016-00134 |
| MDR Report Key | 6204101 |
| Date Received | 2016-12-26 |
| Date of Report | 2017-02-08 |
| Date Mfgr Received | 2017-01-24 |
| Date Added to Maude | 2016-12-26 |
| 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 | PATIENT |
| 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 | 2016-12-26 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| 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 | 2016-12-26 |