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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the capsule was unable to hold the intraocular lens (iol).No further information was provided.
Additional Manufacturer Narrative
If implanted, give date: not applicable, as there is no indication that the lens was implanted if explanted, give date: not applicable, as there is no indication that the lens was implanted; therefore, it was not 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, a definitive response has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: jan.14, 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the lens was received stuck inside of a non-johnson &johnson (j & j) cartridge.The complaint issue could not be confirmed, and no product deficiency could be determined.The complaint issue experienced by the customer may have been the result of attempting to insert a j&j lens with a non-validated for use alcon cartridge per the complaint product directions for use (dfu).Conclusion: as a result of the investigation the complaint issue could not be confirmed to be related to manufacturing and no product deficiency could be identified, the reported issue could not be verified.In review of product investigation results it was confirmed that the complaint issue experienced by the customer may have been the result of attempting to insert a j&j lens with a non-validated for use alcon cartridge per the complaint product directions for use (dfu).Therefore, event is determined to be not reportable.There will no longer be any further reporting under mfr report number 3012236936-2022-00197.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: 13361739
• Report Number: 3012236936-2022-00197
• Device Sequence Number: 4754932
• Product Code: HQL
• UDI-Device Identifier: 05050474531680
• UDI-Public: (01)05050474531680(17)231004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/25/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• 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: 01/04/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 02/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female