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

Model Number	TMICL12.6
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, - 13.50/+4.0/092 (sphere/cylinder/axis), in the patient's left eye (os) on (b)(6) 2019.The lens was reported as having high vaulting and will be explanted/exchanged for a shorter lens.The lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Corrected data: h6: device code: 1583 should be corrected to 3189.B5: lens is reported to be exchanged with a shorter length lens, no reason for exchange was reported.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: b5 - it was reported that the patient experienced excessive vaulting and on (b)(6) 2019 the lens was exchanged with a shorter length lens and the problem was resolved.Postoperative report indicated "patient is happy" and "perfect, improved vision over pre-op".H6 - patient code 3191: no code available (secondary surgery, lens exchange).H6 - device code 1494: off-label use (acd < 3.0mm) h3 - device evaluation: lens was returned in a specimen cup in liquid.Visual inspection found the lens haptic torn.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 - the lens was reported as having high vaulting should be corrected to the lens was reported to be too long.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: 9528016
• Report Number: 2023826-2019-02497
• Device Sequence Number: 18932357
• Product Code: QCB
• UDI-Device Identifier: 00841542107396
• UDI-Public: 00841542107396
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 12/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 02/27/2020; 03/09/2020; 04/16/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 02/27/2020; 03/09/2020; 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR