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

Model Number OPO73

Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Event Description

It was reported that a phaco tubing pack had a crack in plastic carton.It is unknown if there was any patient contact.No other information was received.

Manufacturer Narrative

Section a2, a4, a5 unknown/not provided.Information was requested from the account however, no additional information was provided.Section h6 health effect - clinical code 4582 hs-no patient involvement / no harm.Section h3-other (81): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Section d9: device available for evaluation: yes, returned to manufacturer on 03/24/2023 section h3: device evaluated by manufacturer: yes device evaluation: one (1) sealed opo73 phaco tubing pack received within original packaging confirming the reported lot number.A visual inspection of the returned product reveals the side wall and lip of the tray have been damaged, creating a small opening between the tyvek lid and tray.Visual inspection results were found not within specifications.The reported event is confirmed.Due to the product having been returned without the unit carton to evaluate for damage in the location consistent with the tray, it cannot be determined how and when the damage to the tray occurred.An assignable root cause cannot be identified from the product investigation performed as it cannot be known when the damage occurred to the tray.The outer carton was not returned with the product to determine if the carton was damaged in the same location as the tray as received by the customer.The product met release requirements prior to shipment to the customer.Probable root cause can be attributed to handling of the product post distribution to the customer leading to the tray becoming damaged and breaking the sterile barrier.Manufacturing record review: per manufacturing records review report, no related deviation, ncmr, nc or capa was initiated during the manufacturing conclusion: due to the product being 100% inspected at the manufacturer for damage, how and when damage to the tray occurred cannot be determined due to the product having been returned without the unit carton to evaluate for damage in the location consistent with the tray.Therefore product deficiency by the manufacturer cannot be confirmed.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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16709420
• MDR Text Key: 313130967
• Report Number: 3012236936-2023-00769
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)251022(10)60406563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

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 Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60406563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1