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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information unknown, not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient was experiencing blurry vision immediately post-op and worsening with an intraocular lens (iol).The lens was explanted and the incision was enlarged, however, there was no other medical or surgical intervention reported.No additional information is available.
Additional Manufacturer Narrative
Further information was provided that another johnson & johnson lens (different model and higher diopter) was implanted as a replacement.Section d9: device available for evaluation? yes.Returned to manufacturer on: 1/13/2021.Section h3: device returned to manufacturer? yes.Device evaluation: the complaint lens was received in a specimen cup.Visual inspection under magnification revealed, viscoelastic on the optic body and haptics.And the lens cut in half.Which is consistent with a lens, that was handled during explant.The lens was cleaned, and no other cosmetic defects were observed.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed.And no product deficiency could be identified.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
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the impact code code 4625 incision enlarged provided on the initial report needs to be corrected.Impact code code is no longer applicable and therefore, it is being removed as an impact code.Note: acknowledgement 2 for this report was received on 9/22/2022.There was a delay in receiving acknowledgement 3 due to a cdrh system issue.Therefore, this mdr is being resubmitted at the request of cdrh on 10/19/2022.All pertinent information available to johnson and 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, puerto rico 00610
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco 00610 ; 7142478552
• MDR Report Key: 11137941
• Report Number: 2648035-2021-07028
• Device Sequence Number: 13625422
• Product Code: POE
• UDI-Device Identifier: 05050474605787
• UDI-Public: (01)05050474605787(17)230703
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 10/19/2022

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: 07/03/2023
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/14/2021; 08/29/2022
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/11/2021; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2018
• 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: Male