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 Code	No Code Available (3191)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity, race: unk.Health professional, occupation: unk.(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2 lens,-10.50/1.0/126 (sphere/cylinder/axis) into the patient's eye on (b)(6) 2019.On (b)(6) 2019 the lens was explanted due to excessive vault, and angle closure.No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation : two lenses were returned in liquid, in a specimen cup.Visual inspection found a scratch on a haptic and residue on the lens surface.Refer to mdr 2019-01910 for fellow lens, claim#: (b)(4).
Additional Manufacturer Narrative
Event: the lens was implanted in the patient's right eye (od).Device evaluation should have been reported in supplemental mdr#1.Claim# (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: 9245636
• Report Number: 2023826-2019-01909
• Device Sequence Number: 11232450
• Product Code: QCB
• UDI-Device Identifier: 00841542109093
• UDI-Public: 00841542109093
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2019

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: 11/04/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 12/31/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/12/2019; 12/31/2019
• 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 SFC-45, LOT UNK; FOAM TIP PLUNGER, LOT UNK; INJECTOR MODEL MSIPF, LOT UNK; CARTRIDGE MODEL SFC-45, LOT UNK; FOAM TIP PLUNGER, LOT UNK; INJECTOR MODEL MSIPF, LOT UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR