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

Model Number	DCB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, 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 d6b - explant date: not applicable, as lens remains implanted.Section e1 - email address: unknown/not provided, as information was asked but it was not provided.Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, 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 the preloaded monofocal intraocular lens (iol) was implanted and the cartridge tip was defective.The surgery was completed successfully, no additional surgery steps were needed.Through follow-up we learned that the defective cartridge tip was noticed during contact with the patient's eye; however, the patient was not affected or injured in any way.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 14-nov-2023.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection revealed that the complaint handpiece was received with the plunger rod advanced to the cartridge neck.No additional materials or components were received.The lens module was inspected and no marks that would indicate that the plunger rod advanced incorrectly could be identified.The cartridge tip was cracked and the neck of the cartridge was damaged.There was viscoelastic residue dispersed throughout the length of the cartridge suggesting that an appropriate amount of ophthalmic viscosurgical device (ovd)/balanced salt solution (bss) was used.The handpiece was disassembled and not issues that could cause or contribute to the complaint could be identified.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.Therefore, there is no indication of a product deficiency or product malfunction.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 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: 17865878
• Report Number: 3012236936-2023-02364
• Device Sequence Number: 7041585
• Product Code: HQL
• UDI-Device Identifier: 05050474636200
• UDI-Public: (01)05050474636200(17)260417
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/13/2023

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 Expiration Date: 04/17/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000260
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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