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

Model Number	MICL 13.2
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	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Work order search: 1 similar complaint type event was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, micl13.2, -9.0 diopter, implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2019.Angle closure with elevated iop (35 mmhg) and excessive vault was observed."after an additional lpi, with a round of diamox, combigan, and simbrinza the iop did respond." enlargement of pi, yag, and the anterior chamber irrigation/evacuation of visco/fluids, and additional sutures were done on (b)(6) 2018, per reporter as of (b)(6) 2019 the patient has pain and photophobia.Per reporter as of (b)(6) 2019 the patient's acuity is correctable to 20/20 ou.Reportedly "patient is not interested in replacement at this time.".
Additional Manufacturer Narrative
Enlargement of the peripheral iridotomies was performed by yag laser.Anterior chamber irrigation/evacuation of visco/fluids was performed.An additional suture was required.The icl was explanted on (b)(6) 2019.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8611920
• Report Number: 2023826-2019-00780
• Device Sequence Number: 19271593
• Product Code: MTA
• UDI-Device Identifier: 00841542103275
• UDI-Public: 00841542103275
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Physician
• 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: 07/31/2019
• Device Model Number: MICL 13.2
• 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: 07/15/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/15/2019
• 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#UNK-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#UNK,LOT#UNK; CARTRIDGE MODEL#UNK-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#UNK,LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR