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

Model Number SND1T5

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient was unhappy with her vision.Additional information was provided by the initial reporter, who indicated that the patient was left aphakic due to the cornea being misshaped and the surgeon has chosen to wait.Additional information was provided by the initial reporter, who indicted that the 3 weeks following the iol removal procedure another iol was implanted.The replacement iol is a different lens model and a difference of 1.5 diopters of power.

Manufacturer Narrative

Evaluation summary: the lens was returned in a glass specimen jar filled with a water like liquid.The optic is torn/split/cracked and cut with a large portion of optic lens material missing (not returned).The damage is typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.It is unknown if the qualified products were used.The product investigation could not identify a root cause for the reported complaint.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF RESTOR 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7923483
• MDR Text Key: 122220573
• Report Number: 1119421-2018-01423
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SND1T5
• Device Catalogue Number: SND1T5U150
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Date Manufacturer Received: 11/16/2018
• 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): Required Intervention
• Patient Age: 62 YR