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

Catalog Number 8065750833

Device Problems Inability to Irrigate (1337); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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

An ophthalmic surgeon reported that the anterior chamber was unable to be formed by irrigation during irrigation-aspiration.There was no issue during ultrasound.The situation was the same in spite of irrigation-aspiration handpiece replacement.The surgeon raised the bottle attached to the console, but the condition was considered to be very unstable.The procedure was completed.There was no patient harm.Additional information and product sample have been requested.

Manufacturer Narrative

This is the ninth complaint for the finish goods lot; however, the second for this issue.The device history record review shows the order was built and released per specification.The returned wet sample was visually inspected and it was found that the elastomer was lifted; however, the customers complaint does not referenced an issue of lifted elastomer.The samples were tested without any modifications to the elastomer, the samples passed priming and tune successfully.The pressure of the console pressed the elastomers back in place on the housing.Neither lifting, nor leakage was found after testing.Once the functional testing was completed, a pump segment seal integrity test and an air burst test was preformed, the samples met specifications.The channel of the cassette bases and the elastomers were intact.Root cause: the root cause of the customer¿s complaint is most likely related to the lifted elastomer.The root cause of the lifted elastomer could not be established as the samples passed testing.A possible root cause of the lifted elastomer could be that during the elastomer assembly to the fms housing, the elastomer did not get firmly pressed onto the housing of the fms.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as the root cause is not known and this issue is occurring at a low level and does not present a risk for the patient.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.(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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6087148
• MDR Text Key: 59837755
• Report Number: 2028159-2016-05049
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: INFINITI SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other