MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	DXR00V
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	08/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: unknown/ not provided.Asku.Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po.However, complaint issues reported are not related.Therefore, no further actions are required.Conclusion: as a result of the investigation the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's left eye.The reason for explant was indicated that the patient unhappy with quality of vision, halos and glare.Although, initially indicated that the patient was having glare so yellow tinted lens was put in, but the doctor later clarified that "the glare was not there before the original lens was implanted".Visual issues occurred 1 day post-implant.The replacement lens was a non-johnson & johnson lens.There was no incision enlargement, vitrectomy, sutures done.It was confirmed that the patient was fine post-op.The suspect product was discarded.No other information was provided.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 20729222
• Report Number: 3012236936-2024-000291
• Device Sequence Number: 8305186
• Product Code: POE
• UDI-Device Identifier: 05050474761780
• UDI-Public: (01)05050474761780(17)250720
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/19/2024

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: 07/20/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU195
• 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: 10/22/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2022
• 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 Ethnicity: Non Hispanic
• Patient Race: White