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

Model Number	TMICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in liquid, in a vial.Visual inspection found no visible damage to the lens.(b)(4).No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm tmicl13.2 implantable collamer lens, -9.0/+4.0/070 (sphere/cylinder/axis), in the patient's right eye (od) on (b)(6) 2019.The lens was explanted due to excessive vaulting.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
The reporter indicated the lens was explanted and exchanged on (b)(6) 2019 and problem was resolved.The patient experienced pain and the pain was resolved with icl exchange.The cause of the event was due to sizing nomogram.The patient had lasik ou on (b)(6) 2019 to correct residual astigmatism.Patient code: 3191 - secondary surgical intervention, lens exchanged.(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: 8525151
• Report Number: 2023826-2019-00599
• Device Sequence Number: 2689478
• Product Code: QCB
• UDI-Device Identifier: 00841542108935
• UDI-Public: 00841542108935
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 03/18/2019

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: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/07/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR