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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt.Info.: information unknown/not provided.If implanted, give date: not applicable, as there is no indication that the lens was implanted.If explanted; give date: not applicable, there is no indication the lens has been explanted.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 have been made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was damaged and was observed during procedure in the patient's right eye.Surgeon's opinion is that the patient's anatomy caused or contributed to the event.There was no patient harm or any surgical intervention required.A monarch cartridge was used with duovisc viscoelastic system.It is unclear if the monarch cartridge used with preloaded device or if it was used with replacement lens.A non-johnson & johnson lens was implanted as a replacement.No further information was available.
Additional Manufacturer Narrative
Patient date of birth information was received with product return and the following field was updated: section a-2 patient age/date of birth: (b)(6).Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 25-may-2022.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the handpiece was received with the lens stuck in the cartridge.The cartridge tip was also observed to be damaged.The handpiece was disassembled, and the assembly was inspected, no assembly issues were identified.The complaint lens was removed from the cartridge and cleaned, revealing that it was creased from being folded in the cartridge.Complaint issue of dc-lens 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: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.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: 14416482
• Report Number: 3012236936-2022-01286
• Device Sequence Number: 20221941
• Product Code: HQL
• UDI-Device Identifier: 05050474636194
• UDI-Public: (01)05050474636194(17)250114
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 01/14/2025
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• 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: MONARCH CARTRIDGE
• Patient Sex: Female