MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SEE H10; INTRAOCULAR LENS

Model Number	DXW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the dxw225 intraocular lens (iol) was explanted from the patient's operative eye due to complaints of extreme positive dysphotopsia and persistent halos, glares, starbursts, and bright streaks of light.Replacement lens was a tecnis eyhance iol.Iol is not available for return as it was discarded.No further information is available.
Additional Manufacturer Narrative
Additional information: patient weight and patient ethnicity and race: unknown/asked information unavailable.Date of event: unknown as information was not provided.The best estimate date is between (b)(6) 2023 and (b)(6) 2023 (iol implant and complaint awareness dates).Tecnis symfony toric ii optiblue extended range of vision iol with tecnis simplicity¿ delivery system.Date explanted: unknown/asked information unavailable.The device was not returned for evaluation as it was discarded.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 were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 e. st. andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 16710862
• Report Number: 3012236936-2023-00876
• Device Sequence Number: 19280598
• Product Code: HQL
• UDI-Device Identifier: 05050474763999
• UDI-Public: (01)05050474763999(17)250611
• 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: 2023
• 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): 04/10/2023

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: 06/11/2025
• Device Model Number: DXW225
• Device Catalogue Number: DXW225U120
• 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: 03/19/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2022
• 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: Male