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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: information unknown/asku.Date of event: the exact date is unknown.The best estimate is between the implant and explant dates, (b)(6) 2022.The device has not been returned for evaluation.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.Attempts have been made to obtain the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
It was reported that the j&j iol (intraocular lens) was explanted from the patient's left eye due to them experiencing dysphotopsia.It was unknown if their daily activities were significantly affected.There was no incision enlargement, no vitrectomy, and no sutures required.Reportedly, after the explant the patient fully recovered.No other information was available.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jan 24, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the iol was received cut in half.The lens was cleaned and visual inspection under magnification was performed.Scratches were found on the optic body, and both haptics were bent.No further issues were identified.Based on the return condition of the lens, no further product evaluation could be performed.A product quality deficiency could not be determined.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.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: 16200781
• Report Number: 3012236936-2023-00085
• Device Sequence Number: 4340679
• Product Code: HQL
• UDI-Device Identifier: 05050474529021
• UDI-Public: (01)05050474529021(17)261029
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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 Model Number: ZA9003
• Device Catalogue Number: ZA90030205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/28/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2021
• 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 Age: 61 YR
• Patient Sex: Male