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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section b3: date of event: unknown, information 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 e1: initial reporter: 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 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 after the implantation of a preloaded monofocal intraocular lens, a defect was observed.Consequently, the lens was removed and replaced during the same procedure.Additional information indicated that event date was not noted.There was no report of patient injury.The product was available for return.No additional information was provided.
Additional Manufacturer Narrative
The product was returned to the manufacturing site for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jun 16, 2025.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the plunger rod was fully retracted.The cartridge, lens module, plunger rod, and handpiece were all inspected, and no issues were observed.The lens was removed from the tape it was received on and was cleaned, revealing that the lens was cut in in three places with a portion of the lens missing.Damage was also identified on the lens surface.One haptic was also cut and detached.No further issues were identified.No further evaluation was performed.The complaint issue "lens damage" 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.Conclusion: based on the complaint investigation results, the product was released within specifications.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: 22039763
• Report Number: 3012236936-2025-000141
• Device Sequence Number: 13027063
• Product Code: HQL
• UDI-Device Identifier: 05050474636170
• UDI-Public: (01)05050474636170(17)270615
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: DCB0000245
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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