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

Model Number	NGP680301
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Telephone number: (b)(6).(b)(4).Device evaluation: as a result of this complaint, a field service engineer performed a check of the system.The vacuum values on surgeon mode 2 were checked and as per checklist and vacuum were within specifications.All values relating to the whitestar device were also within specifications, no adjustments or calibrations required.Manufacturing record evaluation: the manufacturing records for the whitestar signature pro system were reviewed.The product was manufactured and released according to specification.A review of the device history record, complaint trending, and risk documentation for this device was performed.There were no discrepancies or non-conformances experienced during manufacturing.The system and its components met all specifications prior to being released.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.The device functioned as intended.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The customer reported that they had problems with occlusion.When switching to mode 2 while doing phacoemulsification on the soft cataract, the machine was not able to suck up the cataract.It kept getting pushed away from the phaco tip.The customer had to switch to ia (irrigation and aspiration) mode and use the hand piece to finish the cataract suction process.They also needed to do a vitrectomy cut due to injury.

• Brand Name: WHITESTAR SIGNATURE PRO
• Common Device Name: 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: 14402616
• Report Number: 3012236936-2022-01243
• Device Sequence Number: 5452000
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2022

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 Model Number: NGP680301
• Device Catalogue Number: NGP680301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown