MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065750833

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problems Burn, Thermal (2530); No Code Available (3191)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A customer reported that during a cataract procedure, the phaco tip occluded and a patient experienced a wound burn, in the left eye.The surgeon was removing the tip from the eye to flush and got to close to the incision while still in position 3 on the foot pedal.Sutures were used to close the wound.Postoperatively, the patient is reported as doing "fine." the phaco tip was not saved for an evaluation.Additional information was received from the customer indicating the occlusion tone was a continuous ding alarm and the machine noted an occlusion.A contact lens was placed in the patient's eye four days postop due to small aqueous leak.The patients outcome is reported as very good.

Manufacturer Narrative

No phaco tip sample was returned for evaluation for the report of a thermal burn due to the tip becoming occluded; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a lot history review could not be conducted.Because a sample was not returned from the customer and no lot information was provided for a lot record review, the root cause for customer complaint issue cannot be determined.Phaco tips are 100% visually inspected by trained operators during the manufacturing process.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7531050
• MDR Text Key: 108856142
• Report Number: 2028159-2018-01045
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Other Device ID Number: 380657508334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OZIL TORSIONAL PHACO HP; TS TIP,45KT,MINI FL AB 0.9MM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR