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

Model Number	ZXT150
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the intraocular lens (iol) was implanted in the patient's operative eye.The power needs to be adjusted and the doctor plans on explanting the iol.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.05-aug-2021 additional information received confirming iol was explanted (b)(6) 2021 and replaced with the same model lens with a different diopter size; thus indicating a calculation issue and not a product issue.It was reported the patient is doing great post-op.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.20-jun-2022 additional information received from duplicate complaint stating patient not happy with results from day 1 post-operative (op).Distance vision was ok, however, patient was unable to read.Intermediate and near vision was also reported as blurry.Patient felt vision was worse than prior to her surgery; hyperopic outcome was also reported.Iol explant date was corrected from (b)(6) 2021 to (b)(6) 2021.There was no patient injury, no vitrectomy performed, and no incision enlargement required.The iol is not available for return as it was discarded by the facility.No further information is available.
Additional Manufacturer Narrative
Device evaluation: product evaluation could not be performed since, at the time of this investigation, the product had not been received/discarded.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.The lens diopter results obtained from the miq electronic system show that this production order (po) was released within diopter specifications.Historical data analysis: a search of complaints revealed that one (01) additional complaint folder was found as part of this production order (po) number - voided duplicate serial number complaint.Based on complaint history review (chr), no escalation was required.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 15005847
• Report Number: 3012236936-2022-01800
• Device Sequence Number: 14032571
• Product Code: POE
• UDI-Device Identifier: 05050474605190
• UDI-Public: (01)05050474605190(17)231015
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

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: 10/15/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U195
• 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: 06/20/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2018
• 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 Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White