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

Device Problem Complete Blockage (1094)

Patient Problem Eye Burn (2523)

Event Type  Injury  

Manufacturer Narrative

(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the patient had a mild burn requiring sutures a while ago maybe up to a year, it occurred during sculpting with phaco.Patient had 20/20 best corrected visual acuity (bcva) following sutures removal several months ago.The patient has not come back for follow up.Doctor provided that the event most likely an inadvertent occlusion known to occur on rare occasions with phacoemulsification.No product will be returned and no further information has been provided.

• 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: 11323138
• MDR Text Key: 231655643
• Report Number: 3006695864-2021-07169
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2021
• Initial Date FDA Received: 02/12/2021
• 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
• Treatment: PHACO WHITESTAR SYSTEM
• Patient Outcome(s): Required Intervention