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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: lens was returned dry, in a specimen cup.Visual inspection found one lens haptic torn, missing piece of haptic and clear residue on lens.(b)(4).
Event or Problem Description
The reporter stated that a micl12.6, -8.0 diopter, implantable collamer lens was implanted on (b)(6) 2017 and explanted on (b)(6) 2017 due to vaulting causing discomfort.The lens was to be replaced with a 12.1 length.Additional information has been requested, but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
No similar claim type was reported for units within the same lot.(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: 6520470
• Report Number: 2023826-2017-00697
• Device Sequence Number: 739296
• Product Code: MTA
• UDI-Device Identifier: 00841542102988
• UDI-Public: (01)00841542102988(17)181231
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 06/19/2017
• 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 AND LOT NUMBER - UNK
• Outcome Attributed to Adverse Event: Required Intervention