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 2020-03-17 for ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM AU00T0 NA manufactured by Alcon Research, Llc - Huntington.
[183721653]
A sample device was not returned for analysis. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. There has been one other complaint reported in the lot number. Additional information has been requested. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183721734]
A physician reported that during an intraocular lens (iol) implant procedure, both haptics were tucked on top of the optic in a correct manner, but upon inserting the lens in the eye, the trailing haptic broke completely from the optic. An enlarged incision was required to remove and replace the iol, and the procedure was completed by suturing the main incision. Additional information was received indicating that postoperatively, the patient experienced blurry vision, the eye is still injected with inflammation and corneal edema with descemets folds.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2020-00454 |
| MDR Report Key | 9841854 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2018-03-23 |
| Date Added to Maude | 2020-03-17 |
| 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 SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM |
| Generic Name | LENS, GUIDE, INTRAOCULAR |
| Product Code | KYB |
| Date Received | 2020-03-17 |
| Model Number | AU00T0 |
| Catalog Number | NA |
| Lot Number | 12605347 |
| 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 | 2020-03-17 |