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

Model Number	ZXT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.If explanted, give date: not applicable, as lens remains implanted.(b)(4).The device is not returning for evaluation as lens remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have 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 a doctor is possibly going to explant an intraocular lens (iol) that was implanted in 2017 due to the patient experiencing glare since surgery.Upon follow-up it was confirmed that the patient has a lens implanted in both the left and right eye.It was noted that the patient is also experiencing halos, but it is unknown when this symptom began.The patient's visual concerns are reported to be debilitating and are significantly interfering with daily activities.Because of this, the patient wants the lenses removed.No other information was provided.This mdr is for report on suspect product in left eye.A separate report will be submitted for the suspect product in right eye.
Additional Manufacturer Narrative
Additional information: upon further follow-up it was noted that the suspect zxt375 +12.5 serial number (sn) (b)(6) was explanted and replaced with zcu375 +13.0 sn (b)(6).The tecnis inserter with platinum cartridge was used.The wound was slightly enlarged but no suture was required.No wound leak.Patient is doing well.Appropriate section in the mdr updated accordingly.Section d6: explant date: (b)(6), 2021.Device evaluation: product evaluation was not performed because the product has not been returned.Complaint report cannot be verified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that one complaint was found as part of this production order although this complaint has been voided.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: visual inspection under magnification revealed two parts of an iol (one part missing).Viscoelastic residue was found on the optic body and haptic, which is consistent with a lens that was handled during explant.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was discovered that the section h4: device manufacture date was incorrectly populated.Correct date is july 19, 2017.Section below updated in this supplemental mdr submission.Section h4: device manufacture date: july 19, 2017.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: 11972639
• Report Number: 9614546-2021-07188
• Device Sequence Number: 4492106
• Product Code: POE
• UDI-Device Identifier: 05050474606821
• UDI-Public: (01)05050474606821(17)220719
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/19/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/22/2021; 10/19/2021; 10/19/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 08/03/2021; 10/19/2021; 10/19/2021
• 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: Other