MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SYMFONY TORIC II; INTRAOCULAR LENS

Model Number	DXW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided, but the best estimate date is between (b)(6) 2023 and (b)(6) 2023.Section h3: other 81: the device was not returned for evaluation as the lens remain implanted in the eye.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It is reported that dxw225 intraocular lens was explanted from patient's right eye due to glare and halo.Dxw225 lens was replaced with diu225 lens successfully.Additional information received revealed that immediately postop, the patient noted severe glare which made it difficult to drive at night.It was confirmed that the lens was removed and replaced in a secondary procedure.There was no patient injury and medical or surgical interventions were not required.Post surgery, the patient's ucva was 20/25, mr(medial rectus) was -0.75 d sphere.It was informed that putting the correction in front of him did not improve the glare.The dxw225 lens was not being returned as it was bisected and not saved.No further information was provided.

• Brand Name: TECNIS SYMFONY TORIC II
• 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: 17240741
• Report Number: 3012236936-2023-01621
• Device Sequence Number: 12439502
• Product Code: HQL
• UDI-Device Identifier: 05050474764309
• UDI-Public: (01)05050474764309(17)250319
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 06/30/2023

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: 03/19/2025
• Device Model Number: DXW225
• Device Catalogue Number: DXW225U275
• 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: 06/05/2023
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2022
• 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
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White