MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT7

Device Problem Overcorrection (3006)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

A sample product was not returned for analysis.The complaint and product history cannot be reviewed as there was no device identifying information provided by the reporter.The root cause of the reported event cannot be determined; however, should additional reportable information become available, a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56.The manufacturer internal reference number is: (b)(4).

Event Description

An account manager reported that a patient was overcorrected by 1.25 diopters of cylinder in the right eye post cataract surgery with toric intraocular lens implant (iol).Additional information received states the iol was rotated.

Manufacturer Narrative

Based on information provided by the facility, the root cause was determined to be unrelated to the product.The healthcare professional indicated that the complaint lens product did not cause or contribute to the event.The file details indicate the surgeon rotated the lens as suggested by (b)(6).The vision improved.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was provided by the physician, that in his opinion, the iol did not cause or contribute to the event.No cause was reported.The patient¿s prognosis is excellent.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10502623
• MDR Text Key: 205952179
• Report Number: 1119421-2020-01224
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN6AT7
• Device Catalogue Number: SN6AT7.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGES; PROVISC
• Patient Outcome(s): Required Intervention