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

Model Number	MICL 13.7 -11.0
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.7 mm micl 13.7 , -11.0 diopter, implantable collamer lens into the patients right eye (od) and removed it on (b)(6) 2018.During initial surgery due to observation of excessive vault and significant reduction of irido-corneal angles.On (b)(6) 2018 the lens was exchanged for a shorter length lens.The exchange resolved the problem.Additional information reported; patient has residual astigmatism with plans for prk (photorefractive keratectomy) in 1 month.
Additional Manufacturer Narrative
Corrected data: (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: 7890067
• Report Number: 2023826-2018-01348
• Device Sequence Number: 16825719
• Product Code: MTA
• UDI-Device Identifier: 00841542103589
• UDI-Public: 00841542103589
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: MICL 13.7 -11.0
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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: INJECTOR#UNK,LOT#UNK,CARTRIDGE#SPFC-45,LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR