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 2020-03-31 for ACRYSOF IQ PANOPTIX TRIFOCAL IOL TFNT00 TFNT00_XXX manufactured by Alcon Research, Llc - Huntington.
[186812086]
Evaluation summary: the product was not returned for analysis. The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation. The product investigation could not identify a root cause. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186812087]
An ophthalmologist reported a poor refraction after an intraocular lens (iol) implant procedure. The patient cannot read after the implantation. Additional information was provided indicating that laser was discussed with the patient for a secondary cataract. Further information has been provided indicating that the iol was implanted into a clinically healthy eye (right eye). During the first four postoperative months, the patient did not have complaints. There is only one alarming point - angiography of both eyes was performed and the uneven microcirculation in the right eye with pronounced areas of ischemia was observed within the normal range for all other parameters of the eyes. Approximately 15 months postoperative the patient had a laser of the posterior capsule performed due the patient experiencing blurry vision. "lacks" near vision (cannot read, cannot work on a computer). The doctor assures that the iol is centered; upon examination with a slit lamp, no defect of the iol was detected. The condition of the optic nerve is normal. During the examination, the patient, being distracted from the goal -? Read? Can read the text lying on the table in front of her, but if you give in hand and ask to read - she complains about the impossibility of completing the task. (the doctor associates this with psychosomatics). According to the doctor, the operation was carried out according to the standard protocol. There are two medical device reports associated with this patient. This report is for the left eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2020-00562 |
| MDR Report Key | 9903358 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-03-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-31 |
| Model Number | TFNT00 |
| Catalog Number | TFNT00_XXX |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-31 |