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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The surgery center initially reported lens defect with an intraocular lens (iol) and that lens was stuck in the cartridge.Additional information clarified the lens itself was damaged, that the iol was partially delivered into the patient¿s right eye and there was contact with the lens.No second instrument needed or change of plan required.Another johnson and johnson lens with the same model and diopter was used as a replacement.No surgical and/or medical interventions were reported.The patient is doing fine post-op and no injury reported.It was indicated that ophthalmic viscoelastic device (ovd) was used as the lubricant which was introduced into the cartridge from cartridge canopy.It was confirmed that the lens was not folded within the cartridge for more than 10 minutes before it was delivered into the patient eye.No further information was provided.
Additional Manufacturer Narrative
Section a4 and a5: unknown/ information asked but not available.Section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.Section h3-other (81): 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, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt was made to obtain the missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: jul 26, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint handpiece and lens were received inside of a bag.A non-jnj lens case was received as well (empty).Visual inspection under magnification revealed that the complaint handpiece was received with the lens stuck to the outside of the cartridge.Inspection of the handpiece revealed that it was received with the plunger rod fully advanced.Further inspection of the cartridge revealed that there was not viscoelastic residue dispersed throughout the length of the cartridge, suggesting that an inadequate amount of ovd was used.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.Visual inspection of the lens revealed that it was received cut in half.The lens was cleaned and, a scratch on the spare tire and optic could be observed.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue "lens damage" was not identified during product evaluation.The observed "cosmetic issue" is similar to the reported complaint issue.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the investigation, no malfunction or product deficiency was 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: 17375726
• Report Number: 3012236936-2023-01899
• Device Sequence Number: 3863599
• Product Code: HQL
• UDI-Device Identifier: 05050474731707
• UDI-Public: (01)05050474731707(17)250727
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: 07/27/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0175
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/22/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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: Female