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

Model Number	DIB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints were received for this po.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Attempts have been made to obtain missing information; however, to date, the information has not been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after implanting a monofocal intraocular lens (iol) into a patient's left eye, the doctor observed a crack at the haptic optic junction.The lens was subsequently explanted and replaced with another lens of the same model and diopter.There was no patient injury reported.No further information was provided.The doctor indicated that this was not the first time that this issue has occurred to him.This report pertains to the issue reported with the dib00 lens, sn (b)(6).A separate report is being submitted for the earlier incident which the doctor experienced.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes.Returned to manufacturer on jun 13, 2025.Section h3.Device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification was performed on the suspect product.The plunger rod was found fully advanced with viscoelastic residue observed to be evenly distributed throughout the cartridge.Stress marks were observed on the cartridge tip but were in speciation for a used device.The lens module and device assembly were inspected revealing no issues.The plunger rod and plunger rod advancement were inspected revealing no issues.The lens was inspected revealing it was received cut in half and stuck together.The lens was unstuck and cleaned revealing two chipped-like marks near the edge of one lens half.No further evaluation was performed.The complaint issue "lens damaged" 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.No product deficiency or product malfunction could be identified.No nonconformity report, documentation or labeling changes, and escalations are required.Johnson & johnson surgical vision will continue to monitor these types of complaints.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: 21352205
• Report Number: 3012236936-2025-000038
• Device Sequence Number: 18101860
• Product Code: HQL
• UDI-Device Identifier: 05050474731714
• UDI-Public: (01)05050474731714(17)270702
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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 Model Number: DIB00
• Device Catalogue Number: DIB00U0180
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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 Sex: Male