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

Model Number	DIU225
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3a, a3b, a4, a5, a6, patient information: unknown/not provided.Section h3, device evaluated by manufacturer: the device has not been 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 the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was dislocated post implantation.The iol was explanted.No further information was provided.
Additional Manufacturer Narrative
Additional information: through follow-up the customer provided additional details.This current report is to provide this information.The customer clarified that during the explant of the johnson (jnj) intraocular lens (iol) there was an anterior capsule rent which likely extended post-operatively.There was no unplanned vitrectomy.The jnj lens was removed from the patient¿s left eye and replaced with a new one using the yamane technique.Sutures were required.No further information regarding the event was provided.Section a3a, sex: female.Section a3b, gender: the customer responded ¿cisgender¿.Section a6, race: the customer responded ¿caucasian¿.Section a5, ethnicity: not hispanic/latino.Section h6- health effect - clinical code: 2639 used to capture the anterior capsule rent.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: through follow-up, the customer provided the following clarifying information.The capsule tore postoperatively once the initial iol was implanted.The capsule rent likely progressed while trying to rotate the initial lens into position.Thus, the rent occurred prior to the second procedure.Resulting in the initial lens being dislocated and needing to be taken out and replaced.The anterior capsule tear (due to the initial johnson and johnson lens) caused a vitreous prolapse which needed to be cleared prior to placing the new lens.The replacement iol is a non-johnson and johnson lens model ct lucia 602 +21.0.Sutures were not needed.No further information was provided.Section h6- health effect - impact code: 4625 used to capture the vitrectomy.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information.Section d9: device available for evaluation? yes section d9: date returned to manufacturer: apr 4, 2025 section h3: evaluated by manufacturer: yes device evaluation: the complaint intraocular lens (iol) was received.The lens was visually inspected under magnification revealing that the lens was cut.Scratches were also observed on the surface of the lens.No further issues were identified.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 21329510
• Report Number: 3012236936-2025-000027
• Device Sequence Number: 8696217
• Product Code: MJP
• UDI-Device Identifier: 05050474747166
• UDI-Public: (01)05050474747166(17)271015
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/12/2025

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 Model Number: DIU225
• Device Catalogue Number: DIU225U215
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 02/12/2025; 03/05/2025; 06/11/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/05/2025; 03/06/2025; 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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: Female
• Patient Ethnicity: Non Hispanic