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

Model Number	TMICL13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pain (1994); No Code Available (3191)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a 13.7mm, tmicl13.7, -10.00/2.0/089 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2019.Shallow anterior chamber and low vault was observed.Patient had elevated iop and pain.The lens was repositioned but the problem was not resolved.The lens was removed and exchanged for a shorter length lens on (b)(6) 2019 and the problem was resolved.Cause of event is reported as "calculator and rep recommended length of lens due to age (13.7mm).13.2mm implanted after explant" of lens.
Additional Manufacturer Narrative
Event: the reporter indicated that a 13.7mm tmicl 13.7 -10.00/2.0/089 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's right eye(od) on (b)(6) 2019.Shallow anterior chamber and excessive vault was observed.Patient had elevated iop and pain.The lens was repositioned but the problem was not resolved.The lens was removed and exchanged for a shorter length lens on (b)(6) 2019 and the problem was resolved.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: 8611930
• Report Number: 2023826-2019-00782
• Device Sequence Number: 1728988
• Product Code: QCB
• UDI-Device Identifier: 00841542111201
• UDI-Public: 00841542111201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/16/2019

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: TMICL13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/18/2019
• 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-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK; CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR