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

Model Number SA60WF

Device Problem Structural Problem (2506)

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

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that an intraocular lens presented with a stripe on the optic.The timing of the event and patient impact are unknown.Additional information has been requested.

Manufacturer Narrative

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

Event Description

New information received stating the event occurred during surgery and the striped intraocular lens (iol) was left implanted.

Event Description

Additional information has been received stating that postoperative, the patient has no complaints of glare or something like that.

Manufacturer Narrative

The product was not returned for analysis.Video review: the provided video shows implanted iol.There appears to be dark marks/lines present on the iol.The exact location of the marks/lines cannot be confirmed.Based on our observation of the attached video, it shows implanted iol, there appears to be dark marks/lines present on the iol.The exact location of the marks/lines cannot be confirmed.A definitive determination of damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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
• MDR Report Key: 8789311
• MDR Text Key: 151123954
• Report Number: 9612169-2019-00198
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/08/2019

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: 10/31/2021
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.105
• Device Lot Number: 21177500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 08/12/2019; 09/16/2019; 11/07/2019
• Supplement Dates FDA Received: 08/13/2019; 09/16/2019; 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALON; MONARCH D CARTRIDGE; MONARCH III INJECTOR