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

Model Number	OPO73
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient info - not provided.Initial reporter: (b)(6).Device history record was reviewed and all devices meet material, assembly, and performance specifications at the time of product release.2 opened opo73 tubing pack were received along with its original tyvek lid confirming the reported lot number.Both samples passed visual inspection.Functional testing was performed for both packs with all results within specifications.The reported issue could not be confirmed.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.All pertinent information available to johnson & johnson has been submitted.
Event or Problem Description
The account reported that they experience poor aspiration during procedure.The posterior capsule rupture occurred in patient's left operative eye.An anterior vitrectomy was done, and the procedure was successfully completed with 3 minutes delay.
Additional Manufacturer Narrative
Additional information: it was reported to jnj that the single use tubing pack was re-used.It is unknown how many times the tubing pack was used.

• Brand Name: WHITESTAR SIGNATURE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 12375450
• Report Number: 2020664-2021-07229
• Device Sequence Number: 4067539
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)240215(10)60282074
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160236
• 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,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2024
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60282074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention