MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC UNK_PHACO TIP/NEEDLE; PHACO ACCESSORY

Model Number	UNKNOWN
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Eye Burn (2523); Unspecified Eye / Vision Problem (4471)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d4 - expiration date: does not apply.Section d6a - implant date: not applicable.Phaco handpiece is not an implantable device.Section d6b - explant date: not applicable.Phaco handpiece is not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).Section h6 -health effect - clinical code: 4471: enlargement of incision.Section h3 - other (81): the material was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during the cataract operation, the surgeon initiated phacoemulsification and the tip of the handpiece abnormally heated and caused a corneal burn and an abnormal enlargement of the incision.This occurred during the first groove phase.The phaco test functioned normally, and the handpiece was initially at a cool temperature.The surgery was stopped to replace the tip and handpiece.The patient's current condition includes two sutures placed following the incision burn.No further information was provided.
Additional Manufacturer Narrative
Correction: after further review of the file it was determined that the suspect product should be the phaco tip and not the ellips phaco handpiece.Section d1 brand name: unk_phaco tip/needle section d2a common device name: phaco accessory section d2b device product code: hqc section d3 establishment name: johnson & johnson surgical vision, inc.31 section d3 country: united states of america section d3 address: 31 technology drive section d3 city: irvine section d3 state: california section d3 zip code: 92618 section d4 model number: unknown as lot number was not provided section d4 catalog number: unknown as lot number was not provided section d4 lot number: unknown as lot number was not provided section d4 primary unique device identification (udi) number: a complete udi # is unknown as product lot number was not provided.A partial number has been provided section g4 pma/510(k) number: k121721.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
The following investigation is for the phaco tip/needle: device evaluation: the product testing could not be performed as the device was not returned.The reported complaint cannot be confirmed.Manufacturing record review: manufacturing record review cannot be performed since the lot number is unknown and cannot be obtained.A complaint historical review of the manufacturing production order number cannot be performed since the lot number is unknown.Conclusion: no sample was returned, and the lot number is unknown, an investigation could not be performed, and no malfunction is confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_PHACO TIP/NEEDLE
• Common Device Name: PHACO ACCESSORY
• 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: 18244022
• Report Number: 3012236936-2023-02895
• Device Sequence Number: 7059637
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK-PHACO TIP/NEEDLE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 09/20/2024; 11/27/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 10/18/2024; 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown