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

Model Number MA60AC

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Visual Impairment (2138)

Event Date 09/17/2018

Event Type  Injury  

Manufacturer Narrative

The product has not been returned to the manufacturing site.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A physician reported that one day following an intraocular lens (iol) implant procedure, the lens rotated and was not stable in the patient's eye.The physician reported the patient's sight was also comprised.The iol was exchanged for another lens of the same model during a secondary procedure.Additional information has been requested.

Manufacturer Narrative

Product evaluation: only a portion of the iol with one haptic still attached was returned.Solution is dried on the lens.The optic is cut, typical of insertion and removal (a large portion containing the other haptic was not returned for evaluation).Dimensional testing could not be conducted due to the extensive optic damage.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause cannot be determined for the reported complaint.Only a portion of the lens containing a haptic was returned for evaluation.Dimensional testing could not be conducted due to the extensive optic damage.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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7965063
• MDR Text Key: 123695451
• Report Number: 1119421-2018-01481
• Device Sequence Number: 0
• Product Code: HQL
• Reporter Country Code: SF
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.165
• Device Lot Number: 12579236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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): Required Intervention