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

Model Number VTICM5_13.2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

Product manufactured but not sold in the u.S.Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -3.0/+4.5/086 (sphere/cylinder/axis), into the patient's left eye (os) on (b)(6) 2017.The surgeon noted refractive surprise.Reportedly, the lens remains implanted.No additional information is available as of the time of mdr submission.

Manufacturer Narrative

The lens was explanted on (b)(6) 2018 due to refractive surprise.The lens was exchanged and the problem was resolved.(b)(4).

Manufacturer Narrative

Device evaluation: the lens was returned dry in a lens case/vial.There was clear surgical residue/debris on product.Visual inspection found no visible damage to the lens and foreign material on lens surface (fibers).Dimensional and functional inspection found the lens to be within specifications.(b)(4).

• Brand Name: 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 7156010
• MDR Text Key: 96223773
• Report Number: 2023826-2017-01970
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 12/06/2017

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: Physician
• Device Expiration Date: 06/30/2020
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 05/15/2018; 07/05/2018
• Supplement Dates FDA Received: 06/06/2018; 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2017
• 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: 38 YR