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

Model Number	TMICL13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Work order search: no similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated a 13.2mm tmicl13.2 implantable collamer lens, - 10.50/+4.0/087 (sphere/cylinder/axis), was damaged/torn during the folding of the lens and when the lens was being pulled through the injector.There was patient contact but no injury.The backup lens was implanted with no problems.The cause of the event was due to a loading error.
Additional Manufacturer Narrative
Date available for evaluation: corrected to 30-oct-2019.Claim# (b)(4).
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid in a lens vial.Visual inspection found haptic torn.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: 9252669
• Report Number: 2023826-2019-02005
• Device Sequence Number: 16644764
• Product Code: QCB
• UDI-Device Identifier: 00841542109147
• UDI-Public: 00841542109147
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/30/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019; 12/30/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 11/14/2019; 12/30/2019
• 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; FOAM TIP PLUNGER MODEL AND LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Age: 38 YR