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

Model Number OPO73

Device Problem Use of Device Problem (1670)

Patient Problem Eye Burn (2523)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

Unknown, as information was requested but not provided.Section d10 medical product: vrt680300 - veritas console - serial number: (b)(6).Laminar flow phaco cvd tip 30d 21g infsl - lot unknown.Model number opocr3021l ellips fx phaco handpiece system- lot unknown.Model number: 690880.Section e1 - telephone number: (b)(6).The device 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.An attempt has been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the tip of the phaco chip was inserted into the patient's eye after capsulorhexis (ccc), resulting in gradual clouding of the incision.This clouding occurred as a result of a crater forming on the crystalline lens due to thermal burn.The intraocular lens (iol) was implanted.The incision was leaking and the anterior chamber collapsed during irrigation and aspiration.The physician handled by holding the incision with fingers.The incision was sutured with two stitches using nylon needle because the hydration was not working and the incision kept leaking, leading to the usage of extra ophthalmic viscosurgical device to complete the procedure.The reporting physician had confirmed in a follow-up examination that the burn had subsided and it has been recovering.Through follow-up, we learned, that the opo73 pack was reused for 11 patients.No further details provided.

• Brand Name: WHITESTAR SIGNATURE
• Type of Device: 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: 19088554
• MDR Text Key: 339927549
• Report Number: 3012236936-2024-01098
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 35050474602084
• UDI-Public: (01)35050474602084(17)260814(10)60487795
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/11/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60487795
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian