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

Model Number	ZXR00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age, weight and ethnicity: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is during 2020.If implanted, give date: unknown, information not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxr00 model intraocular lens(iol) was explanted from patient's eye in a secondary surgical procedure.Additional details received stated that the lens was dislocated and patient had blurred vision.Patient did not have any previous eye conditions.The replacement lens used is a different model, zma00, but same diopter lens.Patient reported no issues since implantation of replacement lens.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed since the product was not returned for evaluation.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.A search revealed that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Upon further review, correction is required as report type selection was missed for product problem and also the implant date was not provided in the previous reports.The following fields have been updated: section b1: report type: product problem (e.G., defects/malfunctions) section d6a: if implanted, give date: (b)(6) 2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation ¿ yes, returned to manufacturer on 1/8/2022 section h3: device returned to manufacturer ¿ yes device evaluation: visual inspection under magnification revealed that the lens was received covered in viscoelastic residue which is consistent with a lens that was handled during explant.The lens was cleaned and no defects were identified.No defects that could contribute to visual issues or device instability were observed.The complaint issue could not be confirmed.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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11277406
• Report Number: 2648035-2021-07184
• Device Sequence Number: 14479995
• Product Code: POE
• UDI-Device Identifier: 05050474579088
• UDI-Public: (01)05050474579088(17)240131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 03/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2022
• 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: 01/06/2021
• Supplement Date Received by Manufacturer: 02/18/2021; 02/18/2022; 03/08/2022
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/16/2021; 02/26/2022; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2019
• 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: Unknown