MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LAMINAR FLOW PHACO TIP; UNIT, PHACOFRAGMENTATION

Model Number OPOCR3021R

Device Problem Complete Blockage (1094)

Patient Problem Eye Burn (2523)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant products: handpiece model 690880 serial (b)(4) ellips fx phaco handpiece system 2.Veritas console serial number (b)(4), phaco tubing pack model opo73 (no lot provided), sleeve opohf21l lot: 60383386.Additional information: johnson & johnson representative was at the account during the event.He examined the phaco handpiece that was used during the event and was not able to find any clogging.He stated that the phaco needle may have been clogged.A review of the records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.H3 other text : see h10.

Event Description

Patient was undergoing cataract procedure and a corneal burn occurred in the patient's left eye.A suture was required.It was reported the phaco needle may have been clogged.

• Brand Name: LAMINAR FLOW PHACO TIP
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15731016
• MDR Text Key: 303049851
• Report Number: 3012236936-2022-02749
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474573321
• UDI-Public: (01)05050474573321(17)250411(10)5345918
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPOCR3021R
• Device Catalogue Number: OPOCR3021R
• Device Lot Number: 5345918
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White