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

Model Number	TMICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pain (1994); No Code Available (3191)
Date of Event	07/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, tmicl13.2, -12.50/3.5/067 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's eye.Reportedly the "lens was removed due to severe pain, lens was wrong length.Surgeon removed lens and did not implant any other lens." additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Supplemental #1 medwatch report in the event description should be corrected to: the reporter indicated that a 13.2mm tmicl13.2, -12.5/3.5/067 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2019.Elevated iop (50 mmhg) without pupil block was observed on (b)(6) 2019.The lens was explanted on (b)(6) 2019.Cause of the event is reported as oversized lens.Per patient's last visit on "(b)(6) 2019, bvca 20/30, iop 20 mmhg, eye status is white and quiet.Iop remained elevated 42 mmhg (b)(6) 2019 despite max medical treatment and aqueous release." claim#: (b)(4).
Additional Manufacturer Narrative
Patient code: 1937.Patient code 3191: no code available (medical intervention).Claim#: (b)(4).
Additional Manufacturer Narrative
Date of event: (b)(6) 2019 should be removed and replaced with unk as it is not applicable.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information received: the reporter indicated that a 13.2mm, tmicl13.2, -13.00/3.5/088 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2019.Elevated iop (52 mmhg) without pupil block was observed on (b)(6) 2019.Lens was removed on (b)(6) 2019.Cause of the event is reported as oversized per reporter, per patient's last visit on (b)(6) 2019, bcva: 20/40, iop: 18 mmhg, eye status white and quiet." (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: 9034019
• Report Number: 2023826-2019-01672
• Device Sequence Number: 19388807
• Product Code: QCB
• UDI-Device Identifier: 00841542109413
• UDI-Public: 00841542109413
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 08/21/2019

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/16/2019; 11/19/2019; 11/20/2019; 11/20/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 09/16/2019; 11/19/2019; 11/20/2019; 11/20/2019
• 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; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR