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

Model Number	TMICL12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 12.6mm tmicl12.6 implantable collamer lens, - 6.50/+2.0/068 (sphere/cylinder/axis), in the patient's eye.The lens was explanted on (b)(6) 2019 due to high intraocular pressure (iop) and excessive vaulting.There was no patient injury.The lens was not replaced with another lens at this time.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Additional data: b5: the reporter indicated the lens was implanted in the patient's right eye (od).The patient experienced glare/halos and blurred vision.A yag was performed to enlarge the pis.Cause of the event was unknown/other (pi's wide enough? needs smaller lens?).The patient's post-op condition was some pigment dispersion.H3: device evaluation: the lens was returned dry in a contact case, with residue on the lens.Visual inspection found one haptic torn.H6 - patient code: 3191 - secondary surgical intervention, yag performed to enlarge pis h6 - patient code: 3191 - pigment dispersion.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b3 - corrected to (b)(6) 2019 in initial mdr.Additional information: b5 - per updated information, the "pigment dispersion has improved but has not yet fully resolved." the patient states "vision has improved since procedure overall." 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: 9528011
• Report Number: 2023826-2019-02495
• Device Sequence Number: 13552928
• Product Code: QCB
• UDI-Device Identifier: 00841542106375
• UDI-Public: 00841542106375
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2019

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: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 12/30/2019; 02/26/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 01/30/2020; 03/27/2020
• 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 MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # UNK.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR