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

Model Number SND1T6

Device Problem Power Problem (3010)

Patient Problem Failure of Implant (1924)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

An ophthalmologist reported that following a multifocal intraocular lens (iol) implant procedure, the target power one month postoperatively was not as he expected.The ophthalmologist reported the iol was implanted as instructed by the calculator, but the director of the facility suspects there was a deviation of the iol add power.The lens was exchanged during a secondary procedure for the same lens model, but one diopter less power.Additional information has been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received indicating the event resolved following the iol exchange.

Manufacturer Narrative

Product evaluation: the lens was returned.Solution and blood were dried on the lens.The optic is torn/cut into pieces, typical of an insertion and removal.The center of the optic has several split/cracked areas.The optic edges have broken areas observed on each of the two lens portions.A power and resolution test could not be conducted due to the lens returned in pieces.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a qualified cartridge and handpiece.Cartridge 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 viscoelastic was not provided.The product investigation could not identify a root cause for the complaint of "deviation of lens power, iol explanted".Power and resolution testing could not be conducted because of the optic damage.Lens damage was observed.Based on our observation it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.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: 7794552
• MDR Text Key: 117558172
• Report Number: 1119421-2018-01162
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: SND1T6
• Device Lot Number: 12539265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 09/11/2018; 10/11/2018
• Supplement Dates FDA Received: 10/05/2018; 11/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR