MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3b: unknown/ not provided.Asku.Device evaluation: product evaluation was not performed because the product has not been received (the device was discarded).The complaint issue reported could not be confirmed.Manufacturing record review: based on the complaint investigation results, the product was released within specifications.A search of complaints related to this production order was performed.The search revealed that no other complaints were received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain missing information; however, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a toric ii intraocular lens (iol) was implanted in a patient's right eye, and they are having intolerable glare and halo a month post op.The doctor is planning to do an iol exchange and change her to a monovision toric, to use the tecnis toric.It was noted that the suspect iol was explanted on (b)(6) 2024.This was replaced with a diu300, same diopter power size as original iol.The doctor did enlarge the incision to about 4 mm to remove the old lens.There was no vitrectomy needed.The doctor also did place 2 sutures in the main incision just as a safety precaution since he had enlarged it.The doctor thought that it is too early to tell if the replacement helped the vision issues because she has some corneal edema and her pupil is still dilated from surgery yesterday, so her vision was very blurry today ((b)(6) 2024), at about 20/50.When the doctor was asked if the halos/glare were gone, she had a hard time answering, likely because of the persistent dilation.The patient is doing just fine, her intraocular pressure (iop) is a little high, likely some retained viscoelastic, so she has a little bit of a headache, but that is improving.Additional information received indicated that the patient's outcome is fine.The explanted lens was discarded.No other information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 20002470
• Report Number: 3012236936-2024-000206
• Device Sequence Number: 17362704
• Product Code: MFK
• UDI-Device Identifier: 05050474752405
• UDI-Public: (01)05050474752405(17)241015
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2024
• Device Model Number: DFW300
• Device Catalogue Number: DFW300U180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White