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

Model Number	MICL 12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: lens was returned in vial, in liquid.Visual inspection found no visible damage to lens.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm micl12.6, -10.0 diopter , implantable collamer lens on (b)(6) 2018.The lens was removed and replaced on (b)(6) 2018 for a shorter length lens due to sizing.This resolved the problem.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
Method code- 4110- work order search found no additional similar complaint type event(s) within associated lot.Correct data date of birth corrected from unk to (b)(6)1991.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8206528
• Report Number: 2023826-2018-01947
• Device Sequence Number: 1961320
• Product Code: MTA
• UDI-Device Identifier: 00841542103022
• UDI-Public: 00841542103022
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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: 10/31/2019
• Device Model Number: MICL 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 03/08/2019
• 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: 27 YR