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

Model Number ASKU

Device Problems Break (1069); Crack (1135); Difficult to Fold, Unfold or Collapse (1254); Defective Component (2292); Wrinkled (2614); Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

There was/were 2 conclusion(s) eval code.There was/were 3 result(s) eval code.There was/were 121 conclusion(s) eval code.There was/were 3 conclusion(s) eval code.There was/were 15 result(s) eval code.There was/were 120 result(s) eval code.There was/were 14 conclusion(s) eval code.The manufacturer internal reference number is: (b)(4).

Event Description

This report summarizes e2000003 138 reported events for q3 2017.There was/were 5 reported event(s) of device code foreign material present in device.There was/were 1 reported event(s) of device code wrinkled.There was/were 1 reported event(s) of device code device damaged prior to use.There was/were 7 reported event(s) of device code scratched material.There was/were 2 reported event(s) of device code use of device issue.There was/were 4 reported event(s) of device code break.There was/were 104 reported event(s) of device code defective item.There was/were 1 reported event(s) of device code crack.There was/were 7 reported event(s) of device code failure to advance.There was/were 1 reported event(s) of device code bent.There was/were 8 reported event(s) of device code difficult to fold or unfold.

Manufacturer Narrative

Corrected information, as follows: there was/were 14 case(s) with a sample received for evaluation, a result code of operational problem and a conclusion code of operational context caused or contributed to event.There was/were 1 case(s) with a sample received for evaluation, a result code of operational problem and a conclusion code of failure to follow instructions.There was/were 1 case(s) with no sample received for evaluation, a result code of operational problem and a conclusion code of failure to follow instructions.There was/were 1 case(s) with no sample received for evaluation, a result code of operational problem and a conclusion code of device not returned.There was/were 120 case(s) with no sample received for evaluation, a result code of no results available since no evaluation performed and a conclusion code of device not returned.There was/were 3 case(s) with a sample received for evaluation, a result code of no failure detected and a conclusion code of no failure detected, device operated within specification.(b)(4).

Event Description

This report summarizes e2000003 138 reported events for q3 2017.There was/were 1 male, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code device damaged prior to use.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code foreign material present in device.There was/were 6 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 4 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 3 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code foreign material present in device.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code bent.There was/were 103 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code defective item.There was/were 1 male, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code use of device issue.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code foreign material present in device.There was/were 7 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code use of device issue.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code wrinkled.There was/were 1 male, unknown age, unknown weight patient(s) with reported event(s) of device code defective item.There was/were 8 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.

• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6986491
• MDR Text Key: 91197294
• Report Number: 1119421-2017-01249
• 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: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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