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	Halo (2227); Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dxr00v intraocular lens (iol) was explanted due to patient could not adjust even though they were provided with several months to adapt.No other information was provided.
Additional Manufacturer Narrative
Section a4, a5, a6: unknown/ not provided.Asku.Section b3: date of event: unknown, not provided.Best estimate of date of event is between jan 3, 2024 and may 22, 2024.Section h3 (no): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have 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.
Additional Manufacturer Narrative
Additional information: information received that the patient was experiencing halos around lights, had difficulty driving and doing her daily chores.The visual issues started 2 -3 weeks after having surgery.No post op injury.Post op outcome was excellent with no complications.Patient noted to be asian / indian patient.Field below updated accordingly.Section a6: race: information received indicated that patient is asian/indian.Section b3: event date: information received that it started 2 -3 weeks after having surgery.Section h6: health effect clinical code: 2227 (to capture halo vision ¿ surgical intervention required).Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed.Based on the complaint investigation results, the product was released within specifications.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search of complaints related to this production order was performed in the system.The search revealed the following: one complaint folder received.The complaint issues reported are not related.Based on complaint handling record results, 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 19536895
• Report Number: 3012236936-2024-000160
• Device Sequence Number: 20376344
• Product Code: POE
• UDI-Device Identifier: 05050474761872
• UDI-Public: (01)05050474761872(17)250413
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 04/13/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU240
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2022
• 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 Age: 77 YR
• Patient Sex: Female