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	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth: unk.Weight: unk.Ethnicity: unk.Race: unk.Device evaluation: the lens was returned in liquid, in a vial.Visual inspection found a haptic torn.(b)(4).Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -6.0 diopter, on (b)(6) 2019.The lens was explanted the same day due to the lens was too large.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
(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: 8457871
• Report Number: 2023826-2019-00472
• Device Sequence Number: 344631
• Product Code: MTA
• UDI-Device Identifier: 00841542102940
• UDI-Public: 00841542102940
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/28/2019

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: 07/31/2020
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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 AND LOT # UNK; INJECTOR MODEL AND LOT # UNK; CARTRIDGE MODEL AND LOT # UNK; INJECTOR MODEL AND LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR