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

Catalog Number 8065750833

Device Problems Device Slipped (1584); Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 02/17/2017

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 surgeon reported that when phacoemulsification was introduced the crystalline lens was dropped into the vitreous.The intraocular lens (iol) was unstable and was therefore removed.It is reported that the procedure was completed.Additional information has been requested.

Manufacturer Narrative

The customer reported that the crystalline lens was dislocated into the vitreous as phaco began.The intraocular lens implant (iol) was placed into the eye but became very ¿unstable,¿ and was subsequently removed.The surgery was completed and after a 30 minute delay and no system messages (sms) were observed.This is an 80 year old female patient.The patient was not hospitalized.There was no drug treatment or second surgery was necessary.Additional, related information was requested but was not obtained.Posterior capsule (pc) tear is a potential consequence of cataract extraction by phacoemulsification.Predisposition to pc tear or zonular dehiscence can be influenced by many factors including, but not limited to, congenital posterior lenticonus, posterior sub capsular (psc) cataract, poor visibility secondary to patients comorbidity [ie.Dense arcus, pterygium, band keratopathy, corneal scars, interstitial keratitis], poor microscope illumination [red reflex], ergonomic obstacles, limited intraocular working space, abnormally long or short axial lengths, pseudoexfoliation, zonular laxity, poor dilation, intraoperative floppy iris syndrome (ifis), dense cataracts, asteroid hyalosis, or inadvertent patient movement.The conditions that increase the risk of pc tear during phacoemulsification include ergonomic obstacles, limited intraocular working space, poor visualization, increased nuclear size and density, weakened zonule, a radial tear in the capsulorhexis, and an inability to rotate the nucleus or epinucleus.These conditions may arise either because of the ocular anatomy, or because of surgical technique.There is no evidence contained within the reported information at this time that indicates that the design or performance of the system had any effect on the integrity of the posterior capsule.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The system was manufactured on june 16, 2008.Based on qa assessment, the product met specifications at the time of release.Posterior capsule tear is an issue that is occasionally reported with cataract surgery.However, a review of the complaint trends shows that the frequency reported is within known levels for this event.A root cause cannot be determined conclusively.(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: 6447117
• MDR Text Key: 71294087
• Report Number: 2028159-2017-01361
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

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 Catalogue Number: 8065750833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2008
• 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: ACRYSOF INTRAOCULAR LENS (IOL)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR