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

Model Number OPO73

Device Problems Reflux within Device (1522); Suction Problem (2170)

Patient Problem Eye Injury (1845)

Event Date 12/25/2023

Event Type  Injury  

Manufacturer Narrative

Section a2 and a4: unknown, as information was requested but not provided.Section d6a implant date: not applicable.Product is not an implantable device.Section d6b explant date: not applicable.Product is not an implantable device; therefore, not explanted.Section e1 telephone number: (b)(6).Section h3 other (81): the opo73 fusion dual pump pack 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 handpiece got detached from the tubing unit during phacoemulsification procedure, resulting in insufficient reflux and the iris being accidentally being aspirated.It became difficult to perform the surgery, and although the crystalline lens was cleaned, an intraocular lens (iol) could not be implanted, so an iol will be implanted at a later date.No further details were 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: 18567578
• MDR Text Key: 333535934
• Report Number: 3012236936-2024-00139
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(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: Physician
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60487795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2023
• 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): Other