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

Model Number MA50BM

Device Problems Malposition of Device (2616); Folded (2630)

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

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the device was received by a company representative and will be sent to the manufacturing site for investigation.Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The iol product history records were reviewed and documentation indicates the product met release criteria.There have been no other complaints reported in the lot number.Cartridge and injector handpiece product history records could not be reviewed because the facility did not provide a lot number or any identification traceable to the manufacturing documentation.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the iol did not unfold properly in the eye; the haptics did not stretch the capsular bag.When attempting push-pull manipulation, the iol slid backward through the capsulorhexis.The iol had to be cut into pieces and removed.Although a standby lens was available, the surgeon did not want to continue working in the affected eye.The patient remains aphakic.Additional information has been requested.

Manufacturer Narrative

Product evaluation: the product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

Additional information was received, indicating that the patient experienced tunnel vision.It was clarified that a replacement lens was not inserted during the initial procedure because the patient's eye should initially repose after removal of the iol.The event is expected to resolve with pending treatment.

Manufacturer Narrative

Product evaluation: the lens was returned positioned incorrectly in the lens case.Viscoelastic and blood are observed on the lens.One haptic is broken distal area in the locking arm mechanism of the lens case (found on the lens case lid).The second haptic is bent-gusset and distal area against a post of the lens case.The optic has been pressed into the well area and against a post, which has split the lens in this haptic insertion area.The optic is also split in the second haptic insertion area.The optic has been cut into two pieces.Fold testing could not be conducted due to the optic damage.The customer indicated the use of a qualified cartridge and handpiece.The cartridge was not returned for evaluation.A non-qualified viscoelastic was used.The root cause for the reported "did not unfold properly" may be related to a failure to follow the dfu; the viscoelastic indicated is not qualified for the lens/cartridge/handpiece combination used.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.The lens was replaced in the lens case incorrectly for return, which caused optic and haptic damage.The lens was also cut in half for removal.We are unable to determine if any of the observed damage occurred before the explant and re-casing of the of the lens.Fold testing could not be conducted due to the optic damage.The cartridge was not returned for evaluation.(b)(4).

• Brand Name: ACRYSOF MULTIPIECE 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: 7151004
• MDR Text Key: 95928400
• Report Number: 1119421-2017-01485
• Device Sequence Number: 1
• Product Code: HQL
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2018

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: 12/31/2021
• Device Model Number: MA50BM
• Device Catalogue Number: MA50BM.245
• Device Lot Number: 12512444
• Other Device ID Number: 00380650698629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/15/2018; 03/09/2018
• Supplement Dates FDA Received: 02/13/2018; 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• 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
• Treatment: MONARCH II A CARTRIDGE; MONARCH II IOL DELIVERY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 73 YR