MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC COMPACT INTUITIV; UNIT, PHACOFRAGMENTATION

Model Number	SCP680300
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Keratitis (1944); Eye Burn (2523)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter telephone number: (b)(6).A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, service history, and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.The review of the device history record (dhr) for the compact intuitiv system showed that there were no issues or non-conformities.The system 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.Based on the investigation results there is no indication of a product quality deficiency.An attempt has been made to obtain missing information; however, to date, no response has been received.
Event or Problem Description
A hospital reported a cataract patient experienced damage to the endothelium as a result of a corneal burn with the use of a compact intutiv system and ellips fx phaco handpiece.Although, the cataract procedure was completed and the lens was implanted in the capsular bag, it was reported surgical intervention was required.In addition, the injury to the damage endothelium may have caused keratitis.Attempts were made to obtain additional information; however, no further information is provided.This report is for the compact intutiv system.A separate report will be submitted for the ellips fx phaco handpiece.

• Brand Name: COMPACT INTUITIV
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 11455478
• Report Number: 3006695864-2021-07310
• Device Sequence Number: 19777311
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K133115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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 Model Number: SCP680300
• Device Catalogue Number: SCP680300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/10/2021
• 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 HP SN.E242035
• Outcome Attributed to Adverse Event: Required Intervention