MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Keratitis (1944); Blurred Vision (2137); Toxic Anterior Segment Syndrome (TASS) (4469); Swelling/ Edema (4577)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted, not explanted.Manufacturer telephone number: (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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there were 6 cases of toxic anterior segment syndrome (tass).It was learned that for this event, the visual symptoms of blurry debilitating, found to have punctate keratitis and mild edema diffusely.Further follow-up confirmed that patient symptoms was tass.Treatment provided was intensive topical steroids.The following meds were also given but was noted as the doctor's standard care, prolensa everyday, inveltys 2x/day, moxifloxican 2x/day, artificial tears, every 1 hour.It was stated that current patient status is that patient doing well, resolved keratitis and edema, best corrected visual acuity (bcva) 20/20.Intraocular lens (iol) remains implanted.No additional medical or surgical intervention required.The other products are not being returned for evaluation.Additional information received noted that the customer investigated the cases.However, root cause for the tass has not been determined.No other information was provided.This report is 5 of 6 cases for tass capturing the event for the intraocular lens (iol).Separate reports are being submitted for each of the other products involved.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 12200466
• Report Number: 9614546-2021-07286
• Device Sequence Number: 3397787
• Product Code: HQL
• UDI-Device Identifier: 05050474657809
• UDI-Public: (01)05050474657809(17)250228
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/20/2021

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: 02/28/2025
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U205
• 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: 06/22/2021
• Initial Report FDA Received Date: 07/20/2021
• 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 Weight: 105