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

Model Number OPO73

Device Problem Contamination (1120)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

Additional narrative information: a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was a thorn on the blue connector of irrigation tube of opo73, and a nurse was hurt with the thorn.The thorn penetrated surgical glove and pricked her skin for less than 1mm.It was not a serious injury, and she is recovering.Customer used the opo73 for a procedure, and the procedure was successfully completed.Customer discarded the opo73 because the product was used for a patient who had contagious disease.Patient was not injured.Although, the product was discarded; the thorn was collected for investigation.No further information provided.

Manufacturer Narrative

Device available for evaluation? yes only foreign matter was returned.Returned to manufacturer: yes.Returned to manufacturer date: 10/3/2022.Section h3.Device evaluated by manufacturer? yes.Section h6 coding type of investigation: 4112.Investigation findings: 202.Investigation conclusions: 4315.Device evaluation: this investigation was initially completed with no sample return.The product was subsequently received.This investigation was reopened in order to document the results of product evaluation.1 of the reported 1 opo73 pack was reported and only a zipped bag containing the suspect foreign material was returned.A photo analysis of the suspected product reveals a piece of foreign material.A visual inspection of the returned product reveals foreign material.How and when the foreign material was introduced cannot be determined.Material could not be identified from inspection under a microscope thus will be sent out for ftir per customer request.The reported issue is confirmed.Ftir analysis primarily revealed the presence of iron, indicating carbon steel or other iron-based metal.The type of metal reported is different than the ones used on the process, considered not the source.Manufacturing record review: according to the reviewed documentation as well as the dhr report of lot 60373238, no discrepancies were found that could be related to the reported failure.Investigation demonstrated that process and current control to verify the defect reported are in compliance by flex.Quality alert for the customer complaint reported was created and placed on the manufacturing line.Based on the present analysis, it is determined that the reported complaint is not related to flex manufacturing process.Conclusion: based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required.Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending 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: 15487126
• MDR Text Key: 306177557
• Report Number: 3012236936-2022-02454
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)250606(10)60373238
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60373238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Race: Asian