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

Model Number OPO71

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  

Manufacturer Narrative

Age, weight, ethnicity: information unknown/ not provided.Per regulation eu (b)(4)(general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Date of event: date unknown/ not provided.Telephone number: (b)(6).The device has 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 and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that when the customer found a stain on the outside and on the inside of the opo71 package.The customer decided to not use it.Through follow up we learnt that the lid of the package was properly closed.The customer said it could have been an issue with the shipping but he is not sure.No additional information was received.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: 21-dec-2022 section h3 - device evaluated by manufacturer? yes device evaluation: a unit of the reported opened opo71 received within original packaging confirm the reported lot number.Photos of the suspect product were attached to the complaint file.A photo analysis reveals a watermark with brown/yellow edges on the top and underside of the tyvek lid.A visual inspection of the returned product reveals a watermark with brown/yellow edges on the top and underside of the tyvek lid.How and when the watermark occurred cannot be determined.The reported issue is confirmed, however, a product deficiency cannot be confirmed due to the opened condition of the returned product.Conclusion: as a result of the investigation, 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 SYSTEM, FUSION PUMP
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15738122
• MDR Text Key: 307107507
• Report Number: 3012236936-2022-02755
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474534445
• UDI-Public: (01)05050474534445(17)250614(10)60374599
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

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: OPO71
• Device Catalogue Number: OPO71
• Device Lot Number: 60374599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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