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

Model Number	TMICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, tmicl13.2, -9.00/1.0/135 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2019.The lens was removed and replaced on (b)(6) 2020 for a shorter length spherical lens due to significant reduction of irido-corneal angles and excessive vault.This resolved the problem.Cause of the event is reported as unknown, patient related factor.
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a ziploc bag with moisture on the lens and clear surgical residue on the lens.Visual inspection found no visible damage to the lens and residue on the lens.Claim#: (b)(4).
Additional Manufacturer Narrative
The reporter indicated that also the cause of event was " smaller than anticipated anatomy based on wtw + ubm".Claim#: (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: 9666978
• Report Number: 2023826-2020-00210
• Device Sequence Number: 11463005
• Product Code: QCB
• UDI-Device Identifier: 00841542108874
• UDI-Public: 00841542108874
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: TMICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020; 02/03/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 02/14/2020; 02/21/2020
• 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-45,LOT#UNK.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR