MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC UNK_PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Keratitis (1944); Blurred Vision (2137); Toxic Anterior Segment Syndrome (TASS) (4469); Swelling/ Edema (4577)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

The device is not returning for evaluation; 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.The clinic is reporting this adverse event only and did not request or require field service or clinical support.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event 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 had 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 handpiece.Separate reports are being submitted for each of the other products involved.

• Brand Name: UNK_PHACO HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 12207153
• MDR Text Key: 263798399
• Report Number: 3006695864-2021-08135
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2021

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 105