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

Model Number SCP680300

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Keratitis (1944); Eye Burn (2523)

Event Type  Injury  

Manufacturer Narrative

Age or date or birth, weight and ethnicity: unknown/ not provided.Date of event is unknown as it was not provided.Email address: unknown/not provided.Initial reporter telephone number: (b)(6).An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event 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.

Manufacturer Narrative

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 phaco 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.

• Brand Name: COMPACT INTUITIV
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 11455754
• MDR Text Key: 238939294
• Report Number: 3006695864-2021-07316
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (y/n): N
• PMA/PMN Number: K133115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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
• Device Operator: Health Professional
• Device Model Number: SCP680300
• Device Catalogue Number: SCP680300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FX HANDPIECE SERIAL NO.E242035; FX HANDPIECE SERIAL NO.E242035
• Patient Outcome(s): Required Intervention