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

Model Number SN6AT6

Device Problem Unintended Movement (3026)

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

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.The root cause has not been identified.(b)(4).

Event Description

A health professional reported that the intraocular lens (iol) rotated after surgery bilaterally; twice in the right (od) eye.The doctor does not know why this happened, but wonders if possibly the capsule is too large.Clarification and additional information have been requested.There are two medical device reports associated with this event; this report is for the patient's right eye.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received via a returned questionnaire.The iol in the patient's right eye was noted to have rotated 90 degrees off axis at the one-day postoperative exam.The following day, the lens was rotated back into position.At the one-day postoperative visit following the rotation procedure, the iol was again noted to be rotated 90 degrees off axis.Five days later, the iol was again rotated back into position, this time by another surgeon.As the patient was referred from another physician and is no longer under the care of the reporting practice, no further follow up information could be provided.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 6790626
• MDR Text Key: 82733067
• Report Number: 1119421-2017-01042
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/25/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6.115
• Device Lot Number: 12383070
• Other Device ID Number: 00380652274166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 08/28/2017
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• 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: 69 YR