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

Model Number OPO73

Device Problems Break (1069); Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown as it was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

A sterility assurance concern was reported.A brief description from the surgery center indicated that there was damage to the opo73 phaco tubing pack tray and they were unsure if the packaging had been comprised and the tubing pack was no longer sterile.

Manufacturer Narrative

Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 1/26/2021.Section h3: device returned to manufacturer: yes.Device evaluation: the sealed opo73 was received confirming the reported lot number 60242584.A visual inspection of the returned product revealed minor cosmetic damage to the universal tray.No breach of the sterile barrier was observed and the tyvek lid seal is still intact.The reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Manufacturer Narrative

H3: a record review was performed.A product deficiency review was performed and there is no product deficiency identified.Device trending was reviewed.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.A labeling review was conducted and found to include adequate instructions for use, warnings and operational errors.The review of the device history record (dhr) for the opo73 fusion dual pump pack, lot #: 60242584 showed that there were no issues or non-conformities.The device and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Based on the investigation results there is no indication of a product quality deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaint.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: WHITESTAR SIGNATURE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 11168071
• MDR Text Key: 227924359
• Report Number: 3006695864-2021-07040
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)230529(10)60242584
• Combination Product (y/n): N
• PMA/PMN Number: K160236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2023
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60242584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/20/2021; 02/23/2021
• Supplement Dates FDA Received: 02/19/2021; 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1