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

Model Number OPOHF20L

Device Problem Contamination (1120)

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

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Additional narrative information: 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.Date of event: unknown/not provided.Telephone number: (b)(6).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.

Event Description

It was reported that a piece of opaque foreign matter entered patient's eye during irrigation/aspiration procedure.The foreign matter was immediately removed with forceps by the surgeon.Procedure was successfully completed with one minute delay.The foreign matter was collected.It was alleged that the foreign mater looked like a fragment originated from phaco tip sleeve.There was no patient injury.No further information provided.

Manufacturer Narrative

Device evaluation: a transparent particle was returned inside a sterile pouch, fixed in place with tape.No phaco sleeve or original packaging were returned.The particle was forwarded to an external lab for material analysis.The foreign material was identified as a silicone species similar to polydimethylsiloxane by comparison with a reference from eurofins eag's library.Without the sleeve being returned, the origin of the silicone particle cannot be determined.However, the opohf20l irrigation sleeve is violet in color.The returned particle is colorless, therefore it is unlikely that it originated from the sleeve.Manufacturing record review: a review of records related to the devices showed all devices meet material, assembly, and performance specifications at the time of product release.Based on the information obtained, there is no indication of product malfunction or product deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending.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: 14232386
• MDR Text Key: 292064263
• Report Number: 3012236936-2022-01110
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474535312
• UDI-Public: (01)05050474535312(17)240423(10)60291931
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPOHF20L
• Device Catalogue Number: OPOHF20L
• Device Lot Number: 60291931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• 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: SIGNATURE CONSOLE, ELLIPS FX PHACO HANDPIECE.