MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	DXW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Date of Event	10/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: sections a-4 patient weight and a-5 patient ethnicity and race: unknown/asked information unavailable.Section b-3: date of event: unknown/asked information unavailable.The best estimation date is between (b)(6) 2023 (iol implant and complaint awareness dates).Section d-6b date explanted: unknown/asked information unavailable.Section h3-81: 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 report 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.
Event or Problem Description
It was reported the dxw150 11.0 diopter model intraocular lens (iol) was implanted into the patient¿s operative eye.In a secondary surgical procedure, the iol was explanted due to complaints of halo effect and poor vision; replacement iol information is unknown.The suspect iol is not available for return as it was discarded.No further information is available.
Additional Manufacturer Narrative
Additional information was received through follow-up confirming no incision enlargement, serious patient injury, suture(s), and vitrectomy.The explanted dxw150 11.0 diopter lens was replaced with a non-j&j iol.Patient outcome post-lens exchange was reported as resolution of symptoms.Patient demographics information was also provided.No further information is available.The following patient codes were updated based on the information received through follow-up: section a-3 patient gender: male, initially reported as no information.Section a-4 patient weight in pounds: 251.Section a-5 patient ethnicity: not hispanic or latino.Section a-5 patient race: white.Section b-3 date of event: (b)(6) 2023.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 18576080
• Report Number: 3012236936-2024-00179
• Device Sequence Number: 7852866
• Product Code: HQL
• UDI-Device Identifier: 05050474762794
• UDI-Public: (01)05050474762794(17)260506
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 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): 02/17/2024

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: 05/06/2026
• Device Model Number: DXW150
• Device Catalogue Number: DXW150U110
• 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: 12/28/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2023
• 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: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White