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	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: unknown/asked information was not provided.Section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the complaint 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 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.
Event or Problem Description
Under a microscope, an additional piece of acrylic was observed on the dib00 model intraocular lens (iol) after its implantation in the patient's operative eye.The iol was removed and replaced with another iol with the same model and diopter.There was no patient injury, no medical intervention, and no surgical intervention during the procedure.Patient prognosis was reported as fine.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes section d-9: device date returned to manufacturer: 06-mar-2026 section h-3: device evaluated by manufacturer: yes device evaluation: the simplicity that corresponds to this complaint was received inside a sealed non-johnson & johnson pouch.A lens was also received in a non-johnson & johnson pouch.The patient stickers, patient implant identification card, and implant notification card were also received.During a visual inspection, the device was inspected under magnification.The lens was cut in half and coated in viscoelastic residue and debris from the foam it was received on.No acrylic particles were identified.The handpiece waws inspected and no issues were identified.The complaint issue "foreign material- loose" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.The manufacturing records for the product and cartridge were reviewed; the units were released in accordance with specifications.A search revealed that no other complaints have been received for this production order.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was 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: 24477708
• Report Number: 3012236936-2026-000056
• Device Sequence Number: 10212678
• Product Code: HQL
• UDI-Device Identifier: 05050474731653
• UDI-Public: (01)05050474731653(17)280624
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: DIB00U0150
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White