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

Model Number	ZCU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from patient's operative eye as other disorders were found during the post-operative examination.A same lens model with different diopter (17.5d) was used as the replacement iol.No further information was provided.
Additional Manufacturer Narrative
Weight and ethnicity: unknown, information not provided.Date of event: unknown, not provided.The best estimate date is between aug 18, 2021 and dec 9, 2021.The device was not returned for analysis.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 missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information : additional information received revealed that the disorders found in the post operative examination was that the patient was unsatisfied with the blurry vision.This made her daily tasks difficult to perform.The original pre-operative visual acuity was 20/80 with correction.Post-implanting with the suspect lens in the left eye, the visual acuity was found to be 20/80 which improved to 20/25 uncorrected after the replacement lens was placed.The patient is now satisfied.Patient weight is 150 lbs.Additional information received from the surgery center revealed that the disorder found in the post operative examination was that the patient was having blurred vision and thus unsatisfied.Fields below updated: section a4: patient weight: 150 pounds.Section h6: health effect - clinical code: 2137 - blurred vision.Corrected data: upon reviewing the complaint folder, it has been determined that even though patient had difficulty in performing the daily tasks due to the blurry vision, the original lens of 20.5d was replaced with a 17.5d lens of same model, with patient satisfied with the vision post- explant.Hence, there is a significant change of 3d between the power of original suspect and the replacement lenses which indicates the possibility of some calculation error during the initial procedure that would have led to the event of blurry vision and the event could not be attributed to some product quality issue of the original lens and hence, the event is no longer considered a reportable event.Therefore, no further information will be submitted under medwatch 3012236936-2022-00077.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: 13196645
• Report Number: 3012236936-2022-00077
• Device Sequence Number: 12227645
• Product Code: HQL
• UDI-Device Identifier: 05050474657809
• UDI-Public: (01)05050474657809(17)250817
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 01/21/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2025
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U205
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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 Sex: Female
• Patient Weight: 68 KG