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

Model Number	ZXT300
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight & ethnicity: information unknown/not provided.Telephone number: (b)(6).An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that an intraocular lens (iol) will be explanted from left eye due to the patient unhappy with the results.Vision is very blurry in the left eye.Lens is well centered, but patient's vision has not improved.Further information was provided that the lens was explanted and replaced with another johnson & johnson lens zxr00 23.5 (different model and higher diopter).There was no patient post-op injury and no medical or surgical intervention required.The patient outcome reported vision is still very fuzzy, patient is not happy, and the lens rotated and flipped axis.No further information was available.
Additional Manufacturer Narrative
Correction: further information was provided with the product return that the explant date was (b)(6) 2021.Therefore, this supplemental filing is to correct the comment initially entered in section d6b.The following section has been updated accordingly: section d6b: if explanted, give date: (b)(6) 2021.Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 7/19/2021.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: complaint lens was received in a specimen container.Visual inspection under magnification revealed that the lens was received cut in half and viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during explant.A detached haptic was also 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.A search of complaints revealed 1 other complaint has been received for this production order number and the complaint met the criteria for no further investigation to be performed; therefore, no product malfunction or deficiency could be identified, and no escalations were required.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.

• 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
• MDR Report Key: 12026301
• Report Number: 9614546-2021-07238
• Device Sequence Number: 11847041
• Product Code: POE
• UDI-Device Identifier: 05050474606388
• UDI-Public: (01)05050474606388(17)230711
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 07/11/2023
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention