MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL TFAT00 TFAT00.235 manufactured by Alcon Research, Llc - Huntington.
[185959384]
Evaluation summary: the product was not returned for analysis. The product history and batch records were reviewed and documentation indicated the product met release criteria. The product investigation could not identify a root cause. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185959385]
A nurse reported that following an intraocular lens (iol) implantation procedure, the patient experienced blurred vision. The lens was exchanged for a different lens within 2 weeks after initial implantation. The reason for the iol exchange was reported as "blurred vision, mechanical complications of iol, visual discomfort in the right eye". Additional information was provided indicating that the event was not the fault of the iol. The patient requested and iol exchange due to the patient wanted a different power to accommodate astigmatism correction. The iol was exchanged for the same model with a difference of 0. 5 diopter in power and the patient is fine and happy with the replacement iol. The iol sample is not available for return. No further information will be provided as the doctor's office is presently closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2020-00507 |
| MDR Report Key | 9881239 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2019-08-30 |
| Date Added to Maude | 2020-03-25 |
| 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 | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | ALCON RESEARCH, LLC - HUNTINGTON |
| Manufacturer Street | 6065 KYLE LANE |
| Manufacturer City | HUNTINGTON WV 25702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 25702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL |
| Generic Name | LENS, MULTIFOCAL |
| Product Code | MFK |
| Date Received | 2020-03-25 |
| Model Number | TFAT00 |
| Catalog Number | TFAT00.235 |
| Lot Number | 12737974 |
| 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 RESEARCH, LLC - HUNTINGTON |
| Manufacturer Address | 6065 KYLE LANE HUNTINGTON WV 25702 US 25702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |