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	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight and race unknown/ asked but not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Device evaluation: the complaint lens was received inside of the original lens case.No additional materials were received.Visual inspection under magnification revealed that the complaint lens was received with a cut in the optic body, that did not sever the lens.The lens was cleaned and, no issues that could cause or contribute to the complaint issue could be identified based on the return condition of the lens, no further product evaluation could be performed.The complaint issue was not confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search in complaint system revealed one additional complaint folder was received for this po.However, complaint issues reported are not related.Therefore, no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.An attempt has been made to obtain missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported after an intraocular lens (iol) was fully inserted in the patient¿s operative eye, the bag broke.The lens was taken out and a different iol, a 3-piece lens was implanted (serial number of replacement lens was not a valid johnson & johnson lens number).The patient outcome was not provided, but it was indicated that there was no injury.No further information was provided.

• 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: 16397313
• Report Number: 3012236936-2023-00411
• Device Sequence Number: 6375349
• Product Code: HQL
• UDI-Device Identifier: 05050474531734
• UDI-Public: (01)05050474531734(17)260613
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2026
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• 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: 01/24/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown