MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC PHACO TIP/NEEDLE; PHACO ACCESSORY

Model Number OPOR3021G

Device Problem Complete Blockage (1094)

Patient Problem Eye Burn (2523)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: signature phaco phacoemulsification unit serial no.(b)(4) and phaco handpiece.(b)(6).The phaco tip is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.In addition, the surgeon was provided training awareness by a johnson & johnsons representative that 21 gauge phaco tips are for single use and advised of parameters ( surgeon settings) for sculpting phaco mode segment.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 Description

During a cataract procedure, a patient experienced a corneal burn as a result of an obstructed single use 21-gauge phaco tip.The corneal burn required sutures to close the wound.The treating surgeon was made of aware by a johnson & johnsons representative that 21 gauge phaco tips are for single use and advised of parameters ( surgeon settings) for sculpting phaco mode segment.The tip is not available for investigation.No further information has been provided.

Manufacturer Narrative

Additional information: b3: date of event: (b)(6) 2021.B5: additional information was provided: the procedure was completed on the same day and two sutures were required to close the wound.At a 2 month post op exam, after the sutures were removed, the patient had seidel that did not resolve with tissue glue or contact lens, so patient had to be brought to the operating room to give a cross and cross suture with a protective therapeutic contact lens.Patient is currently in controls with good visual acuity but with a high astigmatism caused by suture all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: PHACO TIP/NEEDLE
• Type of Device: PHACO ACCESSORY
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 11693353
• MDR Text Key: 246252471
• Report Number: 3006695864-2021-07533
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPOR3021G
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention