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

Model Number MA60BM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Intraocular Pressure Increased (1937); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.The device was received by a company representative and is in transit to the manufacturing site for investigation.Investigation including root cause analysis will be completed.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 12 years after an intraocular lens (iol) was implanted, it was noted to be clouded, yet the patient's vision was still 20/20 without any continuous decrease indicated.Approximately 18 months later, the patient reported blurry vision.Exam determined that the iol was tilted and the capsule was turbid.The patient's intraocular pressure (iop) was increased to 40 millimeters of mercury (mmhg).The surgeon was suspicious that the lens was to blame, but was not sure.Glaucoma eye drop treatment decreased the iop to 25 mmhg.A month later the iop increased to 50 mmhg and vision decreased to 20/50.The lens and capsule were then explanted and another lens was stitched into place.

Manufacturer Narrative

The lens was returned inside a specimen container in clear liquid.The lens is not cloudy in appearance.The lens was removed from the liquid inside specimen container for evaluation.The lens was cleaned with lphse for further evaluation.The optical resolution is acceptable; lens focal length is in the range of a 21.5 diopter.The product investigation could not identify a root cause for the reported events.The lens is clear.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7156361
• MDR Text Key: 96110036
• Report Number: 1119421-2017-01494
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MA60BM
• Device Catalogue Number: MA60BM.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR