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

Model Number	DIB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported central optic defect on delivery of an intraocular lens (iol).The issue was noticed when inserting the lens into the patient¿s right eye.The lens was inserted and removed on the same day.Another lens of the same model and diopter was used as a replacement.No medical or unplanned surgical interventions such as vitrectomy, incision enlargement or sutures required.There was no patient injury reported.The patient was reported to be doing fine post-op.No further information was provided.
Additional Manufacturer Narrative
Section a5: ethnicity: when asked, the race/ethnicity was indicated to be caucasion/white.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 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.Attempts were made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received from the account which the following fields were updated accordingly: section b5: both balanced salt solution (bss) and ankavisc were used for lubrication.No additives used in the bss and it was at room temperature.Anakavisc & bss was introduced into the cartridge from tip as well as the canopy.Section d10: concomitant medical products: balanced salt solution (bss) and ankavisc.Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: may 22, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: he complaint lens was received in a specimen cup.Visual inspection under magnification revealed that the lens was received cut in pieces with a detached haptic.No further defects were observed.The complaint issue of ¿lens damaged¿ was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.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: 16892911
• Report Number: 3012236936-2023-01184
• Device Sequence Number: 6162748
• Product Code: HQL
• UDI-Device Identifier: 05050474731844
• UDI-Public: (01)05050474731844(17)250909
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/19/2023

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: 09/09/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0240
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BSS AND ANKAVISC
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White