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

Model Number	OPOHF21L
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device valuation and conclusion - 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.Section h9: 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 or Problem 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 62 of 62.Separate reports will be submitted for rest of the quantities involved.

• Brand Name: LAMINAR
• 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: 19001841
• Report Number: 3012236936-2024-00954
• Device Sequence Number: 18484879
• Product Code: HQC
• UDI-Device Identifier: 05050474573376
• UDI-Public: (01)05050474573376(17)260717(10)60479361
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/29/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2026
• Device Model Number: OPOHF21L
• Device Catalogue Number: OPOHF21L
• Device Lot Number: 60479361
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H10
• Patient Sequence Number: 1
• Patient Sex: Unknown