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

Model Number	OPO70
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after a normal prime and tune the operation started.During the lens removing process (quadrant) the irrigation was diminishing and suddenly there was a complication.A tear in the capsule of the lens.Therefore a 3 piece iol (intra ocular lens) had to be implanted.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the tubing pack was not returned for evaluation as it was discarded.Therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, lot history, and trending were reviewed.There is not a recognizable adverse trend.The risks and mitigation's associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.The review of the device history record (dhr) for the tubing pack showed that there were no issues or non-conformities.The device and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Conclusion: based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 11485784
• Report Number: 3006695864-2021-07311
• Device Sequence Number: 19792033
• Product Code: HQC
• UDI-Device Identifier: 05050474533479
• UDI-Public: (01)05050474533479(17)231001(10)60260803
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: OPO70
• Device Catalogue Number: OPO70
• Device Lot Number: 60260803
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHACO UNIT UNKNOWN.; PHACO UNIT UNKNOWN
• Outcome Attributed to Adverse Event: Other