MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC LAMINAR; UNIT, PHACOFRAGMENTATION

Model Number OPOHF21L

Device Problem Nonstandard Device (1420)

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 a2, a3, a4, a5: not applicable as there was no patient involvement.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 h3-other (81): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h9: the jjsv reference number is 3012236936-03-11-24-001-r.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 account received a box of opohf21l with only 1 irrigation hole.There is no patient adverse event to report.There was no medical or surgical intervention required.No further information is available.

• Brand Name: LAMINAR
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19009648
• MDR Text Key: 339256716
• Report Number: 3012236936-2024-00786
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/31/2024

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 Model Number: OPOHF21L
• Device Catalogue Number: OPOHF21L
• Device Lot Number: 60479361
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/01/2024
• 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