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

Model Number	OPOR3021R
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that some metal bits was flaking off from the phaco tip during phaco surgery.No further information available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes date returned to manufacturer: 30 april 2024 section h3: device evaluated by manufacturer: yes device evaluation: 2 opor3021r phaco tips received in a bag without original packaging but paperwork included in package indicate products as opor3021r lot # 5185576.Visual inspection of the returned product revealed discoloration on the phaco tips.There is no evidence metal flaking off or loose particles.The reported event is not confirmed.Manufacturing record review: based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.The manufacturing records review for this production order (po) shows that the units were released within specification.No nc/er was found as part of this manufacturing records review.For complaint history review, a search of complaints related to this production order (po) was performed in the system.The search revealed that no other complaints were received for this po.No nonconformity report, documentation or labeling changes, and escalations are required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.

• 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: 19305853
• Report Number: 3012236936-2024-000131
• Device Sequence Number: 6590725
• Product Code: HQC
• UDI-Device Identifier: 05050474573291
• UDI-Public: (01)05050474573291(17)240910(10)5185576
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K121721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: 09/10/2024
• Device Model Number: OPOR3021R
• Device Catalogue Number: OPOR3021R
• Device Lot Number: 5185576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown