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

Model Number SN60AT

Device Problem Folded (2630)

Patient Problem Capsular Bag Tear (2639)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and 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 product investigation could not identify a root cause.Additional information has been requested.(b)(4).

Event Description

A health professional reported that during an intraocular lens (iol) implant surgery, a haptic on an iol was badly folded.The patient experienced a capsular tear.A new lens was inserted and the surgery was completed.Additional information has been requested.

Manufacturer Narrative

The product was returned for analysis and the reported damage was observed.Additional observations were as follows: iol returned positioned incorrectly in the iol case.A significant amount of solution is dried on both surfaces of the optic and haptics.Half of one haptic is broken/torn and not returned.We are unable to determine the root cause for the reported complaint "front haptic badly folded".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on both surfaces of the optic and haptics.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage ( haptic is broken/torn ) would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.All product and batch history records are quality reviewed prior to product release.(b)(4).

• Brand Name: ACRYSOF 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7426966
• MDR Text Key: 105368264
• Report Number: 9612169-2018-00050
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.320
• Device Lot Number: 21168186
• Other Device ID Number: 00380650130525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 82 YR