MAUDE Adverse Event Report: AMO Puerto Rico Mfg. Inc. TECNIS SIMPLICITY; Intraocular Lens

Model Number	DIB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) was fully implanted and subsequently removed during the same surgical procedure due to a posterior capsule rupture.A vitrectomy and sutures were required.The procedure was completed successfully using a replacement non-johnson & johnson lens (model: ma60ac, serial number: (b)(6)).The lens and cartridge came into contact with the patient's left eye.The physician indicated that the device did not cause or contribute to the event.The patient's outcome was reported as fine.Additional information received confirmed that the posterior capsule rupture occurred after implantation of the intraocular lens (iol).The lens was successfully injected into the capsular bag, and the trailing haptic was positioned using a sinskey hook.During removal of the residual viscoelastic with an irrigation/aspiration device, a posterior capsule rupture occurred.The physician did not identify any issues with the lens, cartridge, or implantation process that may have contributed to the event.Furthermore, no preexisting patient conditions were identified as contributing factors.As a result of the posterior capsule rupture, an unplanned anterior vitrectomy was performed, and sutures were required.No other unplanned surgical interventions, such as incision enlargement or additional procedures, were necessary, and no medication outside the standard of care was prescribed.The implanted lens was removed as a direct consequence of the posterior capsule rupture.The patient's current clinical status and visual outcome were reported as stable.No patient injuries or postoperative complications related to the event were reported.The postoperative visual acuity and refraction were reported as 20/30 without glasses.No additional information was provided.
Additional Manufacturer Narrative
Section a4: the weight of 99.3 kilograms did not populate in the field because the system does not accept decimal values.Section d6a: not applicable, as the lens was inserted and removed in the same procedure.Section d6b: not applicable, as the lens was inserted and removed in the same procedure.Section h3: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.Section h6: health effect-impact code:4625-additional surgery (sutures and unplanned vitrectomy).Attempts has been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & 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 ; +1(714)247-8552
• MDR Report Key: 50554029
• Report Number: 3012236936-2026-000256
• Device Sequence Number: 10601146
• Product Code: HQL
• UDI-Device Identifier: 05050474731714
• UDI-Public: (01)05050474731714(17)290105
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: DIB00
• Device Catalogue Number: DIB00U0180
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2026
• 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: 75 YR
• Patient Sex: Female
• Patient Race: White