MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: n/a - lens was not implanted.Section d6b - explant date: n/a - lens was not implanted.Section e1 - telephone number: (b)(6).Section h3: the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of records related to the device including labeling and complaint trending will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.Attempts have been made to obtain missing information.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
It was reported that the preloaded, monofocal, intraocular lens (iol) was "not quite right, defective".There was patient contact with the device but the iol was not fully inserted.No surgical or medical interventions were required.The procedure was completed with a back up iol.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 21-may-2025.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection of the complaint device revealed that the plunger rod was advanced to the lens stuck in the cartridge tip.The lead haptic was unfolded as expected for lens delivery.Viscoelastic residue was not observed to be evenly distributed throughout the cartridge indicating that an inadequate amount of ophthalmic viscosurgical device (ovd) may have been used.Stress marks were observed on the cartridge tip but were in specification for a used device.The lens module was inspected revealing no issues.Device assembly was inspected revealing no issues; viscoelastic residue was observed below the lens module.The plunger rod and plunger rod advancement were inspected revealing no issues.The lens could not be removed from the cartridge tip; however, it was observed to be torn.The lead haptic was also torn.The complaint issue "haptic 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.The other observed issues could not be confirmed to be related to a manufacturing or design issue.Based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM
• 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: 22154825
• Report Number: 3012236936-2025-000136
• Device Sequence Number: 12988315
• Product Code: HQL
• UDI-Device Identifier: 05050474636088
• UDI-Public: (01)05050474636088(17)270925
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: DCB00
• Device Catalogue Number: DCB0000200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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: Unknown