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

Model Number	OPO71
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) , unknown / not provided, unknown / not provided.Device evaluation: the product is not available for investigation, therefore no testing could be performed.The reported event cannot be confirmed.For this lot, all devices meet material, assembly, and performance specifications at the time of product release.Based on the information obtained, there is no indication of product malfunction or product deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints.Despite several follow up attempts, no further information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the packaging of the device was perforated.This was not used on a patient.Despite several follow ups, no further information was provided.
Additional Manufacturer Narrative
Additional information: through follow-up we learned that the inner packaging was found pierced from the outside-in and the shipping box was also damaged.It was learned that the delivery took place on (b)(6) 2022 and the fax was received on (b)(6) 2022.No additional information was provided.The device had the inner packaging broken, as well as the shipping box.No further information was reported.Section h6 - medical device problem code: 2284 - device damaged prior to use.  device evaluation: no product was returned for evaluation.However, an image of the suspect product was provided by the customer.The image depicts an opo71 tubing pack from lot 60305648 with a large puncture through the tyvek lid from the outside in.The reported issue is confirmed, however, how and when the tyvek lid was damaged cannot be determined.Conclusion: based on the information obtained, the reported issue is confirmed.However, how and when the puncture occurred cannot be determined.Therefore, product malfunction and product deficiency cannot be confirmed.Damage indicates that the puncture was introduced from the outside of the packaging inward.There are multiple contributing factors that could contribute the this reported issue such as transportation issue, user handling issue and/or storage issue.A nonconformance was initiated to further investigate this issue and a corrective action will be implemented if required per the non conformance results.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE SYSTEM, FUSION PUMP
• Common Device Name: 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: 14058569
• Report Number: 3012236936-2022-00775
• Device Sequence Number: 11993266
• Product Code: HQC
• UDI-Device Identifier: 05050474534445
• UDI-Public: (01)05050474534445(17)240629(10)60305648
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2024
• Device Model Number: OPO71
• Device Catalogue Number: OPO71
• Device Lot Number: 60305648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown