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	Capsular Bag Tear (2639); Zonular Dehiscence (2698); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens (iol) is not returning for evaluation as it was discarded by the customer; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, and complaint trending 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 a tecnis 1-piece intraocular lens (iol) was displaced because of the patient's capsular bag was compromised.The lens was explanted and vitrectomy was performed.The replacement lens is an anterior lens, za9003 28.5 diopter.Patient outcome is not provided and the lens was discarded.No additional information provided.
Additional Manufacturer Narrative
Correction info.And additional information: based on further review, the following codes were updated to reflect the correct coding per customer responses during the initial intake process.The following fields have been updated: section h6: health effect - clinical code 1.2639 - capsular bag tear 2.4581 - appropriate clinical signs, symptoms, conditions term / code not available - device decentered or dislocated.3.4625 - vitrectomy (inadvertently not coded in initial report submission.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
• MDR Report Key: 11309429
• Report Number: 2648035-2021-07114
• Device Sequence Number: 1283911
• Product Code: HQL
• UDI-Device Identifier: 05050474531949
• UDI-Public: (01)05050474531949(17)211101
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 11/01/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000315
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR