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

Model Number	ZCU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted in a secondary procedure due to blurry vision in the left eye.Another johnson and johnson iol was implanted as replacement (same model, different cylinder of 2.25, same diopter).An incision enlargement was required.There was no patient injury.The patient status was reported as good.No further information was provided.
Additional Manufacturer Narrative
Section a5: race and ethnicity: unknown; requested but not provided.Section d6a: if implanted, give date: unknown, information was requested but not provided.Section d6b: if explanted, give date: unknown, information was requested but not provided.Section h3-other (81): the device was not 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 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.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: sep 5, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, no issues that could cause or contribute to the complaint issue could be identified.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issues were not confirmed.The other observed issue during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as per complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
During a retrospective review, this case was identified as not reportable, as the patient's astigmatism was initially under corrected, resulting in the patient having blurry vision.The lens was explanted and replaced with a higher cylinder toric iol (same model and same diopter) and there was an improvement in patient status with the replacement lens.There was no patient injury and there is no quality issue with johnson & johnson iol.There will no longer be any further reporting under mfr report number 3012236936-2023-02094.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 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: 17547259
• Report Number: 3012236936-2023-02094
• Device Sequence Number: 12497622
• Product Code: HQL
• UDI-Device Identifier: 05050474657663
• UDI-Public: (01)05050474657663(17)241211
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2023

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: 12/11/2024
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U135
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 12/08/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 10/04/2023; 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2019
• 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: Male
• Patient Weight: 100 KG