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

Model Number	OPO73
Medical Device Problem Codes	Reflux within Device (1522); Suction Problem (2170)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	12/25/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 18-jan-2024.Section h3 - device evaluated by manufacturer? yes.Device evaluation: one (b)(6) phaco tubing pack received within a bag.The lot number could not be confirmed.A visual inspection of the returned product reveals the bottle spike tubing had been cut.No other obvious defects or damages were observed.Due to the condition of the returned product, further functional testing could not be performed.The reported event could not be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the phaco handpiece was inadvertently not included in the initial or follow-up#1 mdr reports; therefore, this supplemental mdr report is to correct that information.The following field was updated accordingly: section d10: concomitant medical products: 690880 - ellips fx phaco handpiece all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE
• Common Device Name: 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
• Report Number: 3012236936-2024-00139
• Device Sequence Number: 15223154
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)260814(10)60487795
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160236
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2024

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 Expiration Date: 08/14/2026
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60487795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/24/2024; 12/04/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 05/17/2024; 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELLIPS FX PHACO HANDPIECE, MODEL 690880
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown