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

Model Number	OPOCR3021R
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3012236936-2022-02749
• Device Sequence Number: 7204611
• Product Code: HQC
• UDI-Device Identifier: 05050474573321
• UDI-Public: (01)05050474573321(17)250411(10)5345918
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White