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

Model Number	DCB00
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown, information not provided.Section d6b: if explanted, give date: not applicable, as the lens remained implanted.Section e1: initial reporter: email address: unknown, information not provided.Section e1: initial reporter: telephone number: (b)(6).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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens lead to the haptic unfolded irregularly, which caused the haptic to grasp the posterior capsule and resulted in a ruptured posterior capsule.No other information was provided.
Additional Manufacturer Narrative
Additional information: additional information was received which reported that that the patient recovered well after the removal of a single piece of the implanted device due to the posterior capsule tear, which had prevented proper centering.A three-piece lens was inserted in the sulcus, and an anterior vitrectomy was performed.The patient's vision was 6/12 uncorrected and 6/9+1 corrected, and she was satisfied with the results.No other information was provided.The earlier event code 2199: no health consequences or impact is no longer applicable.The following fields have been updated accordingly: section h6: health effect: impact code: more complex surgery (4631).Section h6: health effect: impact code: additional surgery (4625).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: the device was not returned for evaluation; however, a video was received.Device evaluation: the customer provided video was evaluated by a post market safety surveillance officer.The pictures included in the medical sme memo are screenshots from the video provided by the customer.The pictures show an iol being implanted with a lens claimed to be a tecnis monofocal intraocular lens, preloaded in the simplicity delivery system, model: dcb00.It can be observe the sequence of a lens being implanted, per the sequence, the leading haptic appears to be normally folded and oriented.From the provided video, it cannot be observed abnormalities during the claimed haptic unfolding nor for lens implant sequence.It was not possible to observe the capsule rupture.The complaint issue ¿unfolding issue¿ could not be identified based on the photo and video analysis.Based on the complaint investigation there is no indication of a product deficiency or product malfunction.Manufacturing record review: the manufacturing records review for this purchase order (po) shows that the units were released within specification.No process deviations (dev), nonconformance's (nc/nr), or capas were found as part of this manufacturing records review.Parent po (b)(4) shows that the units were released within specification.Conclusion: based on the complaint investigation results, the product was released within specifications.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 ; 7142478552
• MDR Report Key: 21922681
• Report Number: 3012236936-2025-000117
• Device Sequence Number: 9086030
• Product Code: HQL
• UDI-Device Identifier: 05050474636071
• UDI-Public: (01)05050474636071(17)260924
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2025

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 Expiration Date: 09/24/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000195
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 05/24/2025; 08/05/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/19/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2023
• 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: Other
• Patient Sex: Unknown