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

Catalog Number 8065751763

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Macular Edema (1822)

Event Date 06/06/2018

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 pharmacist reported that a male patient presented with macular edema in the right eye post cataract extraction with intraocular lens implant surgery.Additional medication therapy was required for treatment.The patient is experiencing persistent macular edema.This report is being filed for the ninth patient (single eye) of nine patients.

Manufacturer Narrative

(b)(4).

Event Description

Additional information has been received.There was no adrenaline injection during the procedure.No other products injected during the surgery.No other changes observed since the emergence of cases.

Manufacturer Narrative

(b)(4).

Event Description

Corrected information has been received, it is currently unknown if the patient experienced metamorphopsia.

Manufacturer Narrative

Additional information has been provided.An investigation at the facility has not found a potential cause for this event.Cystoid macular edema (cme), following cataract surgery, states 20% of the patients who undergo uncomplicated phacoemulsification or extracapsular extraction develop angiographically proven cme.A clinically significant decrease in visual acuity is seen only in about 1% of these eyes.If cataract extraction is complicated by posterior capsule rupture and vitreous loss, severe iris trauma or vitreous traction at the wound, there is a significantly higher incidence (up to 20%) of clinically apparent cme, which is unrelated to the presence of an anterior chamber intraocular lens (ac-iol).Clinically significant cme usually occurs within 3¿12 weeks postoperatively.Spontaneous resolution of the cme with subsequent visual improvement may occur within 3¿12 months in 80% of the patients.Cataract surgery in diabetic patients may result in a dramatic acceleration of pre-existing diabetic macular edema leading to poor functional visual outcome.This can be prevented provided the severity of the retinopathy is recognized preoperatively and treated appropriately.Cystoid macular edema is one of the leading causes of poor postoperative visual acuity after cataract surgery in uveitis patients.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 handpiece was manufactured on september 14, 2017.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received indicating the patient received treatment with a diuretic and non steroidal anti inflammatory agent.There has been some decrease but has stalled on ocular coherence tomography.Additional information has been received from health professional.Current ocular coherence (oct) testing shows decrease in edema but persistent.

Manufacturer Narrative

The system was examined and the reported event was not replicated.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on august 17, 2017.Based on qa assessment, the product met specifications at the time of release.(b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The system was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7632738
• MDR Text Key: 112147396
• Report Number: 2028159-2018-01319
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BSS ALCON.; CENTURION OZIL HP.; DEXAFREE.; I/A HANDPIECE.; KSSP 20D C306214.; OCUFEN.; SINGLE USE I/A TIP.; STERDEX.; TOBREX.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR