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

Model Number	DIB00
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Event or Problem Description
After the dib00 model intraocular lens (iol) was implanted the capsule was broken/ripped.During the procedure, the haptics were initially stuck together, and while attempting to place the haptic in the capsular bag, the haptics released, and a tear in the capsule was observed.The lens was subsequently removed.It is unknown if another iol was implanted.The suspect iol is not available for return as it was discarded.No further information is available.
Additional Manufacturer Narrative
Additional information:.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation as it was discarded.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 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 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: 23764656
• Report Number: 3012236936-2025-000331
• Device Sequence Number: 10562113
• Product Code: HQL
• UDI-Device Identifier: 05050474731776
• UDI-Public: (01)05050474731776(17)280729
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0210
• 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: 11/13/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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