MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ZLU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: unknown; requested but not provided.The best estimate date is between (b)(6) 2022 and (b)(6) 2023.Section d6b: if explanted, give date: not applicable, as the lens remains implanted.Section h3-other (81): the device was not returned for evaluation as it remains implanted; 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.Section h6: health effect - clinical code: code 4581 is to capture posterior capsule opacification (pco).Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient has almost the same amount of astigmatism post-implantation of the intraocular lens (iol) in the left eye that there was pre-surgery, but only a different axis.Pre-surgery, the patient had 1.55 diopter of astigmatism and post-surgery the patient has 1.25 diopter of astigmatism.The surgeon noted that it is almost like there is no astigmatism correction in the eye.Post-operative day one, the patient¿s visual acuity (va) was 20/30 and then over time the vision got worse and the patient was experiencing blurry vision.The surgeon performed yttrium aluminum garnet (yag) laser capsulotomy in (b)(6) 2023, as the patient had posterior capsule opacification (pco) and the surgeon thought yag would help with patient¿s blurry vision issue.The patient¿s vision was getting worse prior to yag and then continued to get worse after yag was performed.The patient¿s va went from 20/40 to 20/60.Currently, the patient¿s uncorrected va is approximately 20/50 or 20/60, and corrected va is 20/25 with -1.50 + 1.25 @ 125 with prescription glasses.There is no issue with the lens placement, the lens is in the right place.The patient is a high hyperope and has dry eyes.The surgeon initially thought the dry eye could be the issue, so the patient was put on artificial tears and now restasis.Now the patient is much more lubricated, but vision is still the issue.There was no patient injury.The surgeon is considering performing a limbal relaxing incision, but is not sure it will help much and believes that the patient will still have some of the residual astigmatism.The surgeon is also considering a lens exchange, but is not sure what other lens to implant at this time.No further information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17094422
• Report Number: 3012236936-2023-01432
• Device Sequence Number: 19322071
• Product Code: MFK
• UDI-Device Identifier: 05050474689510
• UDI-Public: (01)05050474689510(17)250320
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/08/2023

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: 03/20/2025
• Device Model Number: ZLU150
• Device Catalogue Number: ZLU150U275
• 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: 05/15/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White