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

Model Number	DIB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.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 a procedure was performed involving the insertion of an intraocular lens (iol).After insertion, the ophthalmologist observed debris on the leading and trailing edges of the lens.Despite various attempts, the debris could not be satisfactorily removed, leading to the removal of the iol by bisecting it.A second iol of the same model and diopter (serial (b)(6) was then inserted.No injury or further intervention was required.No additional information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: device date returned to manufacturer: sept 02, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the plunger rod advanced with the plunger rod tip bent.Viscoelastic residue was observed throughout the cartridge.No issues were observed with the cartridge, lens module, device assembly, and plunger rod advancement.Viscoelastic residue was observed below the lens module.The lens was received cut in half and coated in viscoelastic residue.Further evaluation revealed the lens was damaged; one haptic was scratched and the other haptic was detached.A black material was observed on the remaining portion of the haptic attached to the lens.The lens and foreign material were forwarded to a lab for analysis.Per the lab analysis, ftir testing could not be performed due to insufficient sample; amount of residue available for analysis was extremely limited (less than 50 m).The lens was received back from the lab and was cleaned revealing that the observed material was not embedded in the lens.No further evaluation was performed.The complaint issue was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.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: 22853163
• Report Number: 3012236936-2025-000206
• Device Sequence Number: 15567717
• Product Code: HQL
• UDI-Device Identifier: 05050474731738
• UDI-Public: (01)05050474731738(17)270823
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0190
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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
• Patient Age: 72 YR
• Patient Sex: Female