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 Codes	Vitreous Loss (2142); Capsular Bag Tear (2639)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported after the zcb00 model intraocular lens (iol) was inserted, the patient's capsule was torn/bag was open.The doctor is unsure why the event occurred.The iol was removed and replaced with a 3-piece ar40e 17.0 diopter iol that was implanted into the patient¿s ocular sinister (left eye).There was no medical or surgical intervention required.The patient has been referred to another facility for vitreous prolapse.The suspect iol is not available for return as it was discarded.No further information is available.
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: unknown as information was not provided.Section d-6a date implanted: not applicable as the iol was removed and replaced during the initial procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the initial procedure, therefore not explanted.Section h3: 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 report will be filed.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: 19249241
• Report Number: 3012236936-2024-000129
• Device Sequence Number: 20670422
• Product Code: HQL
• UDI-Device Identifier: 05050474531680
• UDI-Public: (01)05050474531680(17)270614
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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 Model Number: ZCB00
• Device Catalogue Number: ZCB0000185
• Was Device Available for Evaluation?: No
• 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: 04/11/2024
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White