MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC WHITESTAR SIGNATURE FUSION TUBING PACK; PHACO TUBING

Model Number	OPO70
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Patient code is provided for antibiotics administered as medical intervention as a preventative measure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
After a cataract procedure, a scrub nurse at an eye clinic noticed the tubing pack was leaking.The surgery center observed a small hole in one of the tubing lines.As a precautionary measure, antibiotics was administered to the patient due to a possibility of potential contamination from the endosol-balance salt solution that may have regurgitated/irrigated back into the eye.A prescription was ordered for 3 days post op.At a 1-day post op exam, the patient outcome was normal and controlled.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 5/16/2018.Device returned to manufacturer? yes.Device evaluation: the opo70 tubing pack lot# cc03833 was partially returned.Only the drain spike irrigation inlet tubing was returned.A visual inspection of the tubing revealed a crack in the wall of the tubing resulting in a small hole.The reported tear/hole in device is confirmed.Manufacturing record review: per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing the pi lot# cc03833.All devices met material, assembly and performance specifications at the time of product released.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE FUSION TUBING PACK
• Common Device Name: PHACO TUBING
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7376501
• Report Number: 2648035-2018-00423
• Device Sequence Number: 1235916
• Product Code: HQC
• UDI-Device Identifier: 05050474533479
• UDI-Public: (01)05050474533479(17)200329(10)CC03833
• Combination Product (Y/N): Y
• Initial Reporter Country: FI
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018
• Report Date (Section F): 01/01/2005

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: Physician
• Device Expiration Date: 03/29/2020
• Device Model Number: OPO70
• Device Catalogue Number: OPO70
• Device Lot Number: CC03833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHACOFRAGMENTATION UNIT
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005