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

Model Number VTICMO13.2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated that, before implanting a 13.2mm vticmo13.2 implantable collamer lens, -10.5/+0.5/064 (sphere/cylinder/axis) into the patient's left eye (os), it was discovered that there was white sediment on the lens.This occurred on (b)(6) 2021.The lens was not implanted and the cause of the problem is reported as unknown.

Manufacturer Narrative

H3 - device evaluation: lens was returned in a micro-centriuge vial with moisture and debris on the lens.Visual inspection found the lens haptic torn with debris on the lens.Claim#: (b)(4).

Manufacturer Narrative

G4: unable to deselect combination product-please disregard.H3: device evaluation: the lens was returned in a micro-centrifuge vial with moisture on the lens.Visual inspection found that the haptic was torn.No particulate was noted on the lens or in the vial.H6: method code 3331: device history record (dhr) review-based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11400372
• MDR Text Key: 234403488
• Report Number: 2023826-2021-00528
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2021

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: 11/30/2023
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 05/01/2021; 05/05/2021
• Supplement Dates FDA Received: 05/03/2021; 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR