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

Model Number	ZXT375
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Flashers (1864); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable as the device remains implanted.Telephone number: (b)(6).(other): the intraocular lens (iol) is not returning for evaluation as the lens remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During an unmasked clinical research study evaluation of a patient who was bilaterally implanted, the site noted an axis misalignment of the intraocular lens (iol) in the left eye of a patient on (b)(6) 2020.The pre-operative best corrected distance visual acuity (bcdva) of left eye (os) was 20/20.The iol axis placement was at 162 degrees at the time of surgery.At the 1-week visit on (b)(6) 2020, the uncorrected distance visual acuity (ucdva) was 20/60 and bcdva was 20/20.The iol had rotated 38 degrees.The patient reported the following symptoms on (b)(6) 2021: non-directed ocular/visual symptom complaints for the left eye- blurred vision/difficulty with vision distance and near and ghosting.Complaints based on the questionnaire for both eyes- moderately bothered by halos- reading small print; moderately bothered by starbursts- reading signs; moderately bothered by double vision- reading small print; moderately bothered by sensitivity to light- reading; moderately bothered by glare- reading; moderately bothered by poor low light vision reading.It was indicated that the iol repositioning was completed successfully with no patient injury on (b)(6) 2021 as it had been scheduled.There were no interventions such as vitrectomy, incision enlargement or sutures required.The patient outcome was reported as resolved without sequelae.No further information was provided.Only one emdr report is being submitted and that is for the patient's left eye (os).

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11228268
• Report Number: 9614546-2021-07041
• Device Sequence Number: 3637532
• Product Code: POE
• UDI-Device Identifier: 05050474606838
• UDI-Public: (01)05050474606838(17)220222
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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: 02/22/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/25/2021
• 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
• Patient Age: 69 YR