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 Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: unknown/not provided.Section d6a, if implanted, give date: not applicable as the iol was removed and replaced during the same procedure.Section d6b, if explanted, give date: not applicable as the iol was removed and replaced during the same procedure.Therefore, not explanted.Section d10, concomitant medical products: ovd is ophthalmic viscosurgical device and bss is balanced salt solution (bss).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.Section h6- health effect - impact code: 4625 is being used to capture the incision enlargement.An attempt was 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 inserted and then removed within the same procedure.The procedure was completed with a non-johnson and johnson iol.The incision was enlarged but no vitrectomy was required.The patient was not harmed as a result of this event.The event is not related to a miscalculation issue, improper fit, or manufacturer defect.The customer used ophthalmic viscosurgical device (ovd) and balanced salt solution (bss).They allowed both the ovd and bss to acclimatize to the room temperature and there were no delays in the surgery after the inserter was prepped.No further information was provided.
Additional Manufacturer Narrative
Additional information.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: feb 24, 2025.Section h3: evaluated by manufacturer: yes.Device evaluation: the lens was received attached to tape and cut in half.It was inspected under magnification.The lens was removed from the tape and cleaned.The lens presented with no further issues.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 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: 21465516
• Report Number: 3012236936-2025-000052
• Device Sequence Number: 14365795
• Product Code: HQL
• UDI-Device Identifier: 05050474731684
• UDI-Public: (01)05050474731684(17)250407
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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 Expiration Date: 04/07/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0165
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OVD, BSS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown