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

Model Number TMICL12.6

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).One similar complaint type event reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens -6.5/+1.0/087 (sphere/cylinder/axis) into the patient's eye.The surgeon reportedly explanted the lens because the lens is "too big.".

Manufacturer Narrative

B5-additional information: the lens was explanted from the right (od) eye due to excessive vault.The cause of the event is reported as device: "the icl was too large for the eye despite using the optimized wtw measurement." h3-device evaluation: the lens was returned dry in a vial.There was debris on the lens surface.Visual inspection found that the haptic was torn.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
• MDR Report Key: 10491991
• MDR Text Key: 205689161
• Report Number: 2023826-2020-01959
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542106351
• UDI-Public: 00841542106351
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR