MAUDE Adverse Event Report: FLEXTRONICS MEDICAL LAMINAR; UNIT, PHACOFRAGMENTATION

Model Number	OPOS20L
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that phaco tip was loosened during phaco procedure.Customer was able to detach the tip from handpiece by hand.The alleged product was replaced with a brand new phaco tip.Procedure was successfully completed with the backup.There was no patient injury.No further information provided.
Additional Manufacturer Narrative
Initial reporter telephone number: (b)(6).Device evaluated by mfr: other (81): 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.
Additional Manufacturer Narrative
Device available for evaluation? yes returned to manufacturer: yes returned to manufacturer date: 11/14/2022 device evaluated by manufacturer? yes section h6 coding type of investigation: 10 investigation findings: 213.Device evaluation: 1 opened opos20l phaco irrigation sleeve and tip were received within a resealable bag.A visual inspection of the returned product did not reveal any obvious defects or damage.The phaco tip and sleeve were attached to a known good phaco ellips fx handpiece.The tip and sleeve were not found to be loose and the phaco tip could not be removed by hand.The returned tip and sleeve were attached to an ellips fx phaco handpiece (e202839) and a known good opo73 phaco pack (lot# 60212251) on the whitestar signature pro.Prime/tune was commenced and completed successfully.The tip and sleeve were not found to be loose and the phaco tip could not be removed by hand.The reported issue could not be confirmed.Manufacturing record review: per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing.All devices met material, assembly and performance specifications at the time of product released.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: LAMINAR
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): FLEXTRONICS MEDICAL; c. industrial lt. 001 mz 105; no. 20905 int. a cd. industrial; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15840902
• Report Number: 3012236936-2022-02865
• Device Sequence Number: 20329232
• Product Code: HQC
• UDI-Device Identifier: 05050474500389
• UDI-Public: (01)05050474500389(17)240621(10)60302979
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K844373
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 06/21/2024
• Device Model Number: OPOS20L
• Device Catalogue Number: OPOS20L
• Device Lot Number: 60302979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/27/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ELLIPS FX HANDPIECE
• Patient Sex: Unknown