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

Model Number	DXW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Halo (2227)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, a5, a6: unknown/ not provided.Asku.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.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 exchanged/explanted from the patient's right eye.It was noted that visual issues were debilitating.The patient cannot tolerate halos.This was replaced with a non johnson and johnson iol.There was no capsule tear, no vitrectomy, no sutures, no meds outside of standard of care during the surgery.No other information was provided.
Additional Manufacturer Narrative
Additional information: additional information indicated that the replacement lens was a light adjustable lens of 26.0 diopter.The following fields were updated based on the additional information received: section a5: ethnicity: not hispanic/latino.Section a6: race: white (caucasian).Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: jan 23, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection was performed on the suspect product and found lens was cut into three pieces, coated in viscoelastic, and the pieces were stuck together.The lens pieces were cleaned and observed with no further issues.No further evaluation was performed.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The "lens cut" observed during the product evaluation could not be confirmed to be related to the manufacturing or design process.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was also noted that an incorrect date ((b)(6) 2024) was inadvertently entered in section ¿g3¿ of the initial mdr report which is incorrect.The correct date that should have been entered is (b)(6) 2024.Therefore, this supplemental report is to correct that information as indicated below: section g3 date received by manufacturer: (b)(6) 2024 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21048381
• Report Number: 3012236936-2024-000335
• Device Sequence Number: 8399030
• Product Code: HQL
• UDI-Device Identifier: 05050474764293
• UDI-Public: (01)05050474764293(17)250318
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 02/26/2025

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: 03/18/2025
• Device Model Number: DXW225
• Device Catalogue Number: DXW225U270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 01/09/2025; 02/04/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/04/2025; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• 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: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White