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 2020-03-26 for ACRYSOF IQ PANOPTIX TRIFOCAL IOL TFNT00 TFNT00.160 manufactured by Alcon Research, Llc - Huntington.
[186532121]
The product was returned for analysis. The device was received by a company representative and is in transit to the manufacturing site for investigation. Investigation including root cause analysis will be completed. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. There are no other complaints in the lot. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186532122]
A nurse reported that after an intraocular lens (iol) was implanted the patient had discomfort when focusing up close. One month after implantation the lens was exchanged for another lens of one diopter more power. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2020-00517 |
| MDR Report Key | 9883490 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-04-23 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| 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 TRIFOCAL IOL |
| Generic Name | LENS, MULTIFOCAL |
| Product Code | MFK |
| Date Received | 2020-03-26 |
| Model Number | TFNT00 |
| Catalog Number | TFNT00.160 |
| Lot Number | 12705924 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-26 |