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

Model Number	ZA9003
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, there is no indication that the lens was implanted.If explanted, give date: not applicable, there is no indication that the lens was implanted.Hence, not explanted.The intraocular lens (iol) has 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when inserting an intraocular lens (iol) in a patient's right eye, the cartridge tip only had contact when they noticed the haptic was bent.It was indicated that the lens was stuck in the cartridge.The doctor removed and completed the procedure with another johnson & johnson lens with the same model and diopter.There were no surgical and/or medical interventions required.The patient was reported to be doing ok post operation and no patient injury was reported.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes section d9: returned to manufacturer: yes section d9: date returned to manufacturer: mar 10, 2022 section h3: device evaluated by manufacturer: yes device evaluation: the complaint lens was received stuck in the complaint emerald cartridge.The lens was removed and visual inspection revealed a damaged and detached haptic, and lens damage.No further issues identified.The complaint issues "haptic damaged and stuck in cartridge" were confirmed; 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 13539849
• Report Number: 3012236936-2022-00432
• Device Sequence Number: 3684709
• Product Code: HQL
• UDI-Device Identifier: 05050474528994
• UDI-Public: (01)05050474528994(17)261023
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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): 05/12/2022

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 Model Number: ZA9003
• Device Catalogue Number: ZA90030190
• 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: 01/21/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2021
• 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: EMERALD CARTRIDGE, LOT: UNKNOWN
• Patient Sex: Female
• Patient Race: White