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

Model Number	DCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that due to a capsule rupture, there was an intra-operative change of procedure including vitrectomy.There was patient contact with the preloaded intraocular lens (iol) device.No further details were provided.
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section e1 - telephone number: (b)(6).The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending 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 obtain additional information regarding the complaint; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes.Section d9: returned to manufacturer on: 28-jul-2025.Section h3.Device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification was performed on the suspect product.The plunger rod was found overriding a lens that was stuck in the cartridge.Viscoelastic residue was not observed to be evenly distributed throughout the cartridge; the cartridge tip was bent.The lens module was inspected revealing no issues; viscoelastic residue was observed inside the lens module and on the lens module lid.Device assembly inspection revealed no issues; viscoelastic residue was observed below the lens module.The plunger rod and plunger rod advancement were inspected, and no issues were identified.The lens could not be removed from the cartridge for further evaluation.No further evaluation was performed.No issues that could cause or contribute to the complaint issues reported were identified.The other issues observed could not be confirmed to be related to the manufacturing or design process.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.The reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 22294360
• Report Number: 3012236936-2025-000159
• Device Sequence Number: 8467088
• Product Code: HQL
• UDI-Device Identifier: 05050474636170
• UDI-Public: (01)05050474636170(17)271114
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: DCB00
• Device Catalogue Number: DCB0000245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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: Unknown