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

Model Number OPOS20L

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

Event Type  malfunction  

Event Description

It was reported that glittering foreign matters, which looked like small metal particulates, were observed in patient's eye after ultrasonic was used during procedure.The foreign matter was aspirated by irrigation/ aspiration, and the procedure was successfully completed.There was no patient injury.Reportedly the surgeon collected the alleged foreign matter, and the sample will be returned for investigation.Laminar flow phaco tip and guage irrigation sleeve and test both were re-sterilized and reused 2 times.Customer discarded the products; no product will be returned for investigation.This report will capture information for guage irrigation sleeve, a separate report will be submitted for laminar flow phaco tip.No further information was provided.

Manufacturer Narrative

Additional narrative information: patient demographic information requested but not available at the time of this report.Age at time of event: unknown/ not provided.Date of birth and gender: unknown/ not provided.Patient weight: unknown/ not provided.Ethnicity and race: unknown/ not provided.Telephone number: (b)(6).Device evaluation: a review of 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.

• Brand Name: LAMINAR
• 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: 15718313
• MDR Text Key: 305609866
• Report Number: 3012236936-2022-02731
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K844373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPOS20L
• Device Catalogue Number: OPOS20L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2022
• 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
• Treatment: OPOR3020L, 201460109