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

Model Number ASKU

Device Problems Bent (1059); Break (1069); Failure to Fold (1255); Kinked (1339); Defective Component (2292); Component Missing (2306); Inaccurate Delivery (2339); Failure to Advance (2524); Folded (2630); Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

There was/were 2 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 35 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 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 a sample received for evaluation, a result code of improper material 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 manufacturing process problem and a conclusion code of manufacturing deficiency.There was/were 2 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.There was/were 10 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 no sample received for evaluation, a result code of improper material and a conclusion code of device not returned.(b)(4).

Event Description

This report summarizes e2000003 51 reported events for q1 2018.There was/were 3 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code folded.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code kinked.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code defective item.There was/were 9 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code failure to fold.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code bent.There was/were 4 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to fold.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code inaccurate delivery.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 15 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code defective item.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code component missing.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 4 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 8 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code split.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 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code device or device component damaged by another device.

• 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: 7466091
• MDR Text Key: 107231077
• Report Number: 1119421-2018-00478
• 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
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/01/2018
• 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