MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MA60AC

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the lens was loaded incorrectly and had to be removed from the eye.The wound was enlarged.The replacement iol was the same type of lens.The procedure was completed the same day.Additional information was requested.

Manufacturer Narrative

Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury as the wound was enlarged prior to lens use.If the additional information regarding the timing of the event had been received prior to the initial report the event would not have been reportable to the fda.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was provided by the initial reporter, that the wound enlargement and anterior vitrectomy were performed prior to the lens use.According to the surgeon, the performance of the iol did not cause or contribute to the event.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8831675
• MDR Text Key: 152355100
• Report Number: 1119421-2019-01187
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

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 Expiration Date: 09/30/2023
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.220
• Device Lot Number: 12656845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALON; MONARCH II B CARTRIDGE; MONARCH III IOL DELIVERY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 55 YR