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

Model Number SN60WF

Device Problems Crack (1135); Device Slipped (1584); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.Results from the product history record review indicated the iol met release criteria.There have been no other complaints reported in the lot number.A root cause cannot be identified at this time.(b)(4).

Event Description

A health professional reported that during an intraocular lens (iol) implant procedure, the iol was stiff during insertion, the injector probe slipped in a few instances due to incomplete folding of the iol, and the lens stuck with the injector probe in the 2.75 mm incision.The iol was removed from the incision after extension of the wound, and it was noted that there was a crack in the lens.A new lens of the same power was implanted.It was reported that the patient¿s postoperative visit was uneventful, aside from more than usual corneal striae.Additional information has been requested.

Manufacturer Narrative

Product evaluation: the product was returned for analysis and the reported complaint could not be observed.No cartridge was returned.Additional observations were as follows: iol was returned positioned incorrectly in the iol case.A significant amount of solution is dried on both surfaces of the optic and haptics.The optic is torn/split-cut and scratched/marked-rejectable.The iol met specifications when dimensionally measured for edge thickness and plan view.The product investigation could not identify the root cause for the reported complaint as only the iol was returned for evaluation.The dimensions of the lens were tested using an approved template and results show the lens dimensions to be within specification.The manufacturer internal reference number is: (b)(4).

• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6556085
• MDR Text Key: 74790134
• Report Number: 9612169-2017-00083
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

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: 05/31/2021
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.220
• Device Lot Number: 21165490
• Other Device ID Number: 00380655093238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: 07/28/2017
• Supplement Dates FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• 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
• Treatment: UNSPECIFIED CARTRIDGE; UNSPECIFIED INJECTOR
• Patient Outcome(s): Other