MAUDE Adverse Event Report: STAAR SURGICAL COMPANY ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

Model Number VTICMO12.1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyclitis (1799); Vitrectomy (2643); No Code Available (3191)

Event Date 09/26/2015

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Lens not returned.(b)(4).A lens work order search was performed and no similar complaints were found within the work order.Based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.1mm vticmo12.1 implantable collamer lens, -12.0/+4.0/x087 diopter, in the patient's right eye (od) on (b)(6) 2015.The lens was explanted on (b)(6) 2015 due to patient experienced cyclitis.After the lens was explanted, the patient was transferred to tertiary hospital for pas plana vitrectomy (ppv).

Manufacturer Narrative

(b)(4).Device evaluation: product evaluation found that the lens was returned dry in the lens case/vial.There was clear surgical residue/debris on the product.Visual inspection found the lens to have no visible damage.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5291931
• MDR Text Key: 33342124
• Report Number: 2023826-2015-01634
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

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: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: VTICMO12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 12/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2015
• 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: 33 YR