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

Model Number	ZA9003
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon had planned on using a preloaded intraocular lens (iol), model pcb00, as it is their standard practice.However, halfway through phacoemulsification, a small capsule tear was observed.Account's brief description of the event provided that the surgeon requested a 3-piece lens (suspect iol, model: za9003, 25.5 diopter power) and implanted it in the sulcus.The surgeon did not notice that the haptic was bent until the lens had been deployed inside the capsule and decided to replace the lens.Account believes that the bent haptic was a handling/loading problem.It was indicated that the incision was enlarged with a a 5.2 blade to pull the remainder of the partially cut lens out of the patient's left eye as it was difficult to remove the lens.By the time the iol was completely removed, the capsule had deteriorated further and could no longer support another sulcus lens.Therefore, a competitor anterior chamber lens (23.5 diopter power) was implanted and suturing was required to close the incision.The case was about an hour long, triple the surgeon's usual time.It was provided that 20 mg of triamcinolone was administered due to the excessive manipulation of the eye.Patient was reportedly okay post operation.The iol was discarded post removal.No further information was provided.
Additional Manufacturer Narrative
Date of birth: the exact date of birth was asked but the information is unavailable, only the year of birth of 1941 was provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(6).The device is not returning 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.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.

• 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: 14365940
• Report Number: 3012236936-2022-01216
• Device Sequence Number: 14858357
• Product Code: HQL
• UDI-Device Identifier: 05050474529120
• UDI-Public: (01)05050474529120(17)230719
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030255
• 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: 04/13/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2018
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White