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

Model Number	OPO73
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that white foreign material came out from the gap between the phaco tip and the sleeve and entered in the patients eye during a cataract procedure.The foreign material was removed from the eye with forceps and the procedure was completed.There was no patient harm.
Additional Manufacturer Narrative
Age or date of birth, sex, weight and ethnicity unknown/no information was provided.(b)(6).Concomitant medical product - handpiece s/n unknown, phaco tip opor3021r, lot unknown, sleeve lot unknown.A review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews was performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 12724904
• Report Number: 2020664-2021-07946
• Device Sequence Number: 4028764
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)240528(10)60298885
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2024
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60298885
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1