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

Model Number	TMICL12.6
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Device code 2993 in previous mdr is not applicable.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8497481
• Report Number: 2023826-2019-00582
• Device Sequence Number: 1781510
• Product Code: QCB
• UDI-Device Identifier: 00841542107358
• UDI-Public: 00841542107358
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC, LOT#UNK; CARTRIDGE MODEL: SFC, LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR