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

Model Number	DFW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4 and a5: unknown, information was requested but not provided.Section b3: date of event: unknown, not provided, but the best estimate date is between feb 15, 2024 and may 30, 2024.Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints were received for this po.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Attempts were made to obtain the missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
A doctor reported that a patient has blurry vision with a toric intraocular lens (iol) and that the patient does not have vision they are satisfied with.It was indicated that the patient did not like the feeling of filmy vision, even with correction ( refractive se was -0.25).The doctor was planning to explant and replace the iol.Through follow ups, it was learned that the explant occurred on (b)(6) 2024 and that a johnson & johnson toric lens of different model and lower diopter (dxw225 5.5d) was implanted in the patient¿s left eye as a replacement.No other ocular issues reported.It was noted that during the lens exchange there appeared to be quite a lot of capsular fibrosis and even some contracture.Nevertheless, the exchange appeared to be successful.There are no other planned procedures.No patient injury reported.No further 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: 19602547
• Report Number: 3012236936-2024-000178
• Device Sequence Number: 7195450
• Product Code: MFK
• UDI-Device Identifier: 05050474751576
• UDI-Public: (01)05050474751576(17)241012
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/24/2024

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: 10/12/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U060
• 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: 06/03/2024
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Race: Native Hawaiian Or Other Pacific Islander