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

Model Number TMICL12.6

Device Problems Failure to Unfold or Unwrap (1669); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.Device evaluation: lens was returned stuck in cartridge.The cartridge was returned in lens box.There was residue on product.Visual inspection found no visible damage to the device and residue on cartridge.Claim # (b)(4).

Event Description

The reporter indicated that a 12.6mm, tmicl12.6, -13.5/2.0/093 (sphere/cylinder/axis), implantable collamer lens would not open/unfold properly during injection into the right eye (od).The incision was widened and sutures were used.The lens was implanted, removed and exchange within the same surgery and the problem was resolved.The reporter stated "no problems" for patients current condition.

Manufacturer Narrative

Device code 2993 in previous mdr is not applicable.(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 91016
• MDR Report Key: 8497481
• MDR Text Key: 141390966
• Report Number: 2023826-2019-00582
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542107358
• UDI-Public: 00841542107358
• 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: 03/13/2019

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC, LOT#UNK; CARTRIDGE MODEL: SFC, LOT#UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR