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

Model Number	ZA9003
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the iol (intraocular lens) was fully inserted into the patient¿s right eye.The haptic ripped off during insertion.The iol was cut into pieces to remove it and will not be returned for evaluation as it was discarded.It was also reported that the patient¿s capsule tore.The doctor attempted to implant za9003 21.0 diopter however, was unable to use that as well.The procedure was subsequently completed with iol model zcb00 21.5 diopter.The patient¿s daily activities were not affected by this event, and have fully recovered.
Additional Manufacturer Narrative
Account reported they don't have that information.If implanted, give date: not applicable as the iol was inserted and removed within the same procedure.If explanted, give date: not applicable as the iol was inserted and removed within the same procedure.The device was not returned for evaluation as it was discarded.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 the missing information; however, to date, no response has been received.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: date returned to manufacturer: mar 3, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the johnson and johnson (jnj) analyst was notified that a detached haptic was returned to the jnj irvine location (partial return).As the evaluation is not done at the irvine location, then the product was forwarded to the jnj jacksonville location where an evaluation will be performed.No complaint lens was received for evaluation.Visual inspection under magnification revealed that a haptic piece removed from the lens was received.Haptic detached cannot be confirmed without the complete lens (unable to observe if the haptic was removed from the lens drill hole).The emerald30c cartridge was evaluated and cartridge tip damage was observed.The cartridge appeared to have been used.No other cartridge damage was observed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.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: 16433509
• Report Number: 3012236936-2023-00419
• Device Sequence Number: 15315398
• Product Code: HQL
• UDI-Device Identifier: 05050474529045
• UDI-Public: (01)05050474529045(17)250904
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030215
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2020
• 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: EMERALDC CARTRIDGE CH15743.
• Patient Age: 82 YR
• Patient Sex: Female