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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the intraocular lens (iol) was implanted in the right eye, the surgeon noticed the zonular fibers loose and not stable.There was a capsule tear.It was decided that it was better to put a 3 piece lens in instead.The surgeon cut and removed lens.Another johnson and johnson iol was implanted as replacement (different model, za9003, different diopter of +24.0).Triamcinolone suspension was used to visualize the vitreous and miostat was injected in the anterior chamber to constrict the pupil.An anterior vitrectomy was performed and a suture was added to close the wound.The suture and vitrectomy were unplanned.Patient is doing ok post-operatively and wants to have the other eye done.Visual acuity is 20/40 with no improvement (ni).Intraocular pressure (iop) of 25.The patient was scheduled to have a goniotomy done after the cataract case but the surgeon cancelled it.There was no malfunction or issue with the iol.The device was discarded.No further information was provided.
Additional Manufacturer Narrative
Patient's race: unknown; requested but not provided.The customer reported "other." 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.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.Health effect - impact code: cod 4625 is to capture both unplanned vitrectomy and sutures.Health effect - clinical code: code 4581 is to capture eye anatomy issue.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: 16418733
• Report Number: 3012236936-2023-00376
• Device Sequence Number: 5631919
• Product Code: HQL
• UDI-Device Identifier: 05050474531802
• UDI-Public: (01)05050474531802(17)261005
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

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: 10/05/2026
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000245
• 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: 01/27/2023
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30, (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic