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

Model Number	DCB00
Medical Device Problem Codes	Crack (1135); Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: if implanted, give date: unknown/not reported; it is unknown if the iol had any patient contact or if it was implanted.Section d6b: if explanted, give date: unknown/not reported; it is unknown if the iol had any patient contact or if it was implanted.Section e1: telephone number: (b)(6).Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device 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 and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) injector broke in the patient's operative eye and there was an unfolding issue.No further information was provided.
Additional Manufacturer Narrative
Additional info: through additional information received, it was learned that the lens was introduced into the eye and partly through injection, the injector cracked near the tip.The injector and the lens were removed from the eye and new intraocular lens was inserted.There was no patient injury.There was no medical or surgical intervention outside of standard of care.No further information was provided.The following sections have been updated accordingly: section a2: age/date of birth: (b)(6) 1950.Section a3a: sex: male.Section a3b: gender: cisgender man/boy.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 5/23/2025.Section h3: device evaluated by manufacturer¿ yes.The complaint handpiece and lens was received loose inside a biohazard bag.Visual inspection under magnification revealed the complaint handpiece was received with the plunger rod partially advanced.Viscoelastic residue was observed to be evenly distributed throughout the cartridge.The cartridge tip was observed to be torn, and the tear extended to the cartridge tube.The lens module was inspected revealing no issues.Device assembly was inspected revealing no issues.The plunger rod and plunger rod advancement was inspected revealing no issues.The lens was inspected revealing it was received coated in viscoelastic residue.The lens was cleaned revealing no issues.The complaint issue "cartridge tip cracked/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.The complaint issue "unfolding issue" 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 issue.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson and 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: 21869303
• Report Number: 3012236936-2025-000104
• Device Sequence Number: 7916595
• Product Code: HQL
• UDI-Device Identifier: 05050474636132
• UDI-Public: (01)05050474636132(17)270827
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2025

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: DCB0000225
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 05/28/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/20/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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