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

Model Number OPOHF21L

Device Problems Nonstandard Device (1420); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: note: this mdr report is being submitted as part of a remedial action to prevent serious injury.Section b3: date of event: unknown/not provided.Section d6a: if implanted, give date: not applicable as this is not an implantable device.Section d6b: if explanted, give date: not applicable as this is not an implantable device.Section e1: initial reporter: name: unknown, information not provided.Section e1: initial reporter: email address: unknown, information not provided.Section e2: initial reporter: health professional: unknown, information not provided.Section e3: initial reporter: occupation: unknown, information not provided.Device evaluation - the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.Based on the information available, product malfunction and deficiency are confirmed.Section h9: the jjsv reference number is (b)(4).The number was omitted due to the complaint handling system character limitation.Johnson & johnson surgical vision (jjsv) has initiated a field action related to select lots of laminar® flow irrigation sleeve and test chamber ¿ 21 gauge (part number: opohf21l) due to a manufacturing issue which could lead to subpar performance during cataract surgery.While not all the irrigation sleeves in the recalled lots are affected, this nonconformance could lead to insufficient flow of balanced saline solution (bss), which may result in an unstable anterior chamber.This defect could result in a capsule tear, iris trauma, or corneal edema, or in rare instances a corneal incision burn.Complaints will continue to be monitored and investigated.Investigation is ongoing and corrective action will be implemented as appropriate.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that customer had opohf21l sleeves that have 1 irrigation port only.Application support specialist was at the account and confirmed the sleeves on hand have had the same issue with 62 sleeves affected (8 boxes, 14 singles) of lot 60479361.There was no patient or case impact.The sleeve issue was caught during set up.No further information is available.This report is 28 of 62.Separate reports will be submitted for rest of the quantities involved.

• 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: 18996839
• MDR Text Key: 339250011
• Report Number: 3012236936-2024-00894
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474573376
• UDI-Public: (01)05050474573376(17)260717(10)60479361
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPOHF21L
• Device Catalogue Number: OPOHF21L
• Device Lot Number: 60479361
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1