MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis and the reported complaint could not be observed.The intraocular lens (iol) returned pressed down into well area of iol case base, resulting in deformation of the iol.Solution is dried on both surfaces of the optic and haptics.A dried reddish colored solution (possibly blood) is present on the lens.Both haptics are adhered to the optic surface in a folded position solution.Unable to conduct dimensional testing due to condition of returned sample.The product investigation could not identify the root cause for the reported complaint "came out too early".The reported complaint is lacking in relevant information such as associated hand-piece used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the iol contributed to the event.A functional test (dimensional) to check the dimensions of the lens could not be conducted due to the condition of the returned sample.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that during an intraocular lens (iol) implant surgery, the lens came out too early and was not folded.The surgery was completed with another lens.There was no patient impact.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jason michaelides ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686438
• MDR Report Key: 9676279
• MDR Text Key: 182287692
• Report Number: 9612169-2020-00045
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.190
• Device Lot Number: 21158981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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