MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXT150
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight: unknown/not provided.Implant date: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Explant date: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Email address: unknown, information not provided.Telephone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) had a white substance on the haptic of lens.The surgeon implanted and explanted the lens at the time it was observed and successfully replaced the lens with another johnson & johnson lens (same model and diopter).There was no unplanned vitrectomy, incision enlargement, or sutures required.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation? yes returned to manufacturer on: 8/25/2021 device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics as well as being cut in half.Furthermore, a substance was identified on the haptics holding the two lens halves together.The alleged foreign material was observed and was forwarded to eag laboratories for further analysis.Per eag laboratories, the foreign material is identified as an acrylic based adhesive or sealant containing fillers consistent with calcium carbonate and aluminum silicate.The fourier transform infrared (ftir) spectrum raw data output file generated by eag laboratories was then compared against the groningen manufacturing process ftir library and did not yield any results with at least a 0.90000 correlation.The top hit was ¿000000606headcaproundelastic¿ with a 0.585145 correlation.The complaint issue was confirmed, however due to the low correlation (correlation less than 0.90000) between the foreign material and the groningen manufacturing process ftir library, it cannot be confirmed to be related to manufacturing, as groningen has manufacturing controls in place to prevent the release of product with foreign material on it.Therefore, no product deficiency could be identified.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; van swietenlaan 5; groningen, groningen 9728 -NX ; NL 9728 NX
• MDR Report Key: 12221128
• Report Number: 9614546-2021-07300
• Device Sequence Number: 14528437
• Product Code: POE
• UDI-Device Identifier: 05050474605312
• UDI-Public: (01)05050474605312(17)220210
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• 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: 06/28/2021
• Supplement Date Received by Manufacturer: 08/13/2021; 11/30/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/19/2021; 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2017
• 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
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White