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

Model Number SN60WF

Device Problem Scratched Material (3020)

Patient Problems Failure of Implant (1924); Increased Sensitivity (2065); Blurred Vision (2137); Anxiety (2328); Depression (2361)

Event Date 01/29/2016

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The results from the product history record review 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

An attorney reported on behalf of a patient that the "left intraocular lens (iol) was found sometime after the surgery to be defective".The attorney indicated the patient saw a second surgeon who noted that the iol in the left eye was centered and had central linear abrasions on the implant.The surgeon said that there were multiple "scuff marks" on the left implant.The attorney alleges that the patient sustained the following injuries, some or all of which are or may be permanent: worsened vision in the left eye, light sensitivity, and, nervousness, frustration, emotional tension, anxiety and depression as the result of the surgery.No further information is expected.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was provided by an attorney on behalf of the patient that the surgery was a cataract extraction/vitrectomy/intraocular lens (iol) implant procedure.Further information regarding the surgery products used was provided by one of the surgeons and the surgery facility.

Manufacturer Narrative

(b)(4).

Event Description

Additional information provided indicates that there was significant posterior capsular stria and opacification contributing to decreased best corrected visual acuity.

Manufacturer Narrative

(b)(4).

Event Description

Additional information provided by a physician through medical records that the patient has no complaints at this time.The posterior capsular haze is not obscuring vision.Discussed option of yag cap lens when quality of vision is affected.Observation only at this time.Multiple "scuff marks" on iol, discussed risks for replacing iol, vision still reasonably good, would not recommend replacing lens and patient does not want any more surgery.Recommend observation.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE 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: 7032852
• MDR Text Key: 92058236
• Report Number: 1119421-2017-01310
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/07/2018

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: 01/31/2020
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.175
• Device Lot Number: 12351957
• Other Device ID Number: 00380655093146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 01/26/2018; 06/13/2018; 08/13/2018
• Supplement Dates FDA Received: 02/23/2018; 07/12/2018; 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• 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
• Patient Age: 60 YR