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

Model Number OPO73

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)

Event Type  Injury  

Event Description

It was reported that symptoms that seem to be toxic anterior segment syndrome (tass) have occurred in an unknown number of patients.No further details were provided.Separate reports will be submitted for the other system components that were used on the patients.

Manufacturer Narrative

Section a2 and a4: unknown, as information was requested but not provided.Section b3 - date of event: date unknown, as information was requested but not provided section d4: lot number lot#: unknown/not provided.Section d4: udi #: a complete udi # is unknown as device lot number was not provided.Section h4.Device manufacture date: unknown, as the lot number of the device was 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 device was not evaluated 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.Attempts have 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.

• 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: 18125931
• MDR Text Key: 328000447
• Report Number: 3012236936-2023-02673
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)(10)UNKNOWN
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian