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, -8.0/+4.0/094 (sphere/cylinder/axis), in the patient's left eye (os).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 lens was implanted on 25-feb-2019 and explanted on 27-mar-2019.The patient experienced pain and the pain was resolved after icl exchange.The lens was exchanged for a shorter lens and the problem was resolved.The patient had lasik ou on 14-may-2019 to correct residual astigmatism.The cause of the event was due to sizing nomogram.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: 8525163
• Report Number: 2023826-2019-00598
• Device Sequence Number: 19505440
• Product Code: QCB
• UDI-Device Identifier: 00841542108799
• UDI-Public: 00841542108799
• 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