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

Model Number	TMICL13.2
Medical Device Problem Codes	Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, -7.00/2.0/111 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2020.Blurred vision and possible refractive surprise was observed.Reportedly, "a white fibrous membrane adherent to posterior icl." lens remains implanted.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
B5-the reporter indicated that a 13.2mm tmicl 13.2 of -7.0/2.0/089 (sphere/cylinder/axis) implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020.The surgeon reports a white fibrous membrane adherent to posterior icl.The patient experienced blurred vision and durezol drops were prescribed.The surgeon tried to remove membrane with low power laser energy anterior to icl with no success.The lens was explanted on (b)(6) 2020.D6a- (b)(6) 2020.H3- device evaluation: lens returned in a specimen cup with residue on product.Visual inspection found no visible damage to lens and residue on lens.H6- health effect: 4624- low power laser energy anterior to icl.Corrected data: g4- in previous mdr should be corrected to 14-oct-2020.H6-type of investigation code 4110: updated erial number lens work order search: no additional similar complaint type event(s) within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: d4: reported as (b)(6).Updated / corrected to (b)(6).D9: reported as no.Updated / corrected to yes, 04/nov/2020.H4: reported as 11/oct/2018.Updated / corrected to 29/oct/2018.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: 10678723
• Report Number: 2023826-2020-02357
• Device Sequence Number: 2909579
• Product Code: QCB
• UDI-Device Identifier: 00841542108614
• UDI-Public: 00841542108614
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 10/15/2020; 12/03/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/03/2020; 12/05/2020
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR