MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE PRO; UNIT, PHACOFRAGMENTATION

Model Number	NGP680301
Medical Device Problem Codes	Suction Problem (2170); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: unknown/ not provided.Section d6a - implant date: implant date does not apply because the lens was removed during the same procedure.Section d6b - explant date: explant date does not apply because the lens was removed during the same procedure and has never been implanted.Section e1 - email address: unknown, information not provided.Section e1 - telephone number: (b)(6).Section h3 - other (81): 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.Section h6 health effect - clinical code 4581 - incision enlarged.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.
Event or Problem Description
It was reported that there was a case of sudden posterior vesicle damage which occurred during irrigation/aspiration (ia) step for removal of ophthalmic viscosurgical device (ovd) on the patient's right eye.The doctor thinks there is a possibility that there is a problem with the suction of ia due to the ia tip.The physician has been using sigpro for more than three years, but this is the first time to have these issues.Through follow-up we learned, that an istent was used and posterior capsule damage during ovd removal after intraocular lens (iol) implantation.The iol implanted was a dfw375 serial number: (b)(6) due to patient injury this lens was explanted, and the following lens was implanted: ar40e 21.5d serial number: (b)(6).Diamox was prescribed due to increased intraocular pressure.A vitrectomy was performed and the incision to the eye was enlarged, requiring sutures.The operation on the patient's left eye was postponed.No other complications were reported and healon na 0.85 was used for these case without issues related to it.No further details were provided.A separate report is being submitted for the other jnj device involved for this patient.

• Brand Name: WHITESTAR SIGNATURE PRO
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18400970
• Report Number: 3012236936-2023-03304
• Device Sequence Number: 14146518
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NGP680301
• Device Catalogue Number: NGP680301
• Was Device Available for Evaluation?: No
• 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: 12/06/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2019
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian