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

Model Number TMICL13.2

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon noted the edge of a 13.2mm tmicl13.2 implantable collamer lens, - 7.00/+1.5/092 (sphere/cylinder/axis), was not smooth and did not use.There was no patient contact and the backup lens was used.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

H3: device evaluation: the lens was returned in liquid in lens vial.Visual inspection found one haptic torn.The lens was viewed under 10x, the torn haptic was noted but no other observations.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 9880944
• MDR Text Key: 190936611
• Report Number: 2023826-2020-00654
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542108607
• UDI-Public: 00841542108607
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

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: 09/30/2020
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR