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

Model Number	MICL 12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth: unk.Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm, micl12.6, -10.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2019."doctor saw that the lens was cracked." the lens was removed and exchanged on (b)(6) 2020.No injury to patient.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
H3 - device evaluation: the lens was returned dry in a zip lock bag with residue on the lens.Visual inspection found the haptic torn and residue on the lens.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: b5- "the doctor noticed low vault, refractive surprise and elevated iop.The exchange resolved the problem." should be added to the initial mdr.H6- medical device problem code 1401 - refractive surprise.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: a2- (b)(6) 1987, should be in the previous mdr.B3- (b)(6) 2020, should be in the previous mdr.H6- clinical code 1937 should be in previous mdr.H6- device code 1583 should be in previous mdr.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: 9633715
• Report Number: 2023826-2020-00177
• Device Sequence Number: 3141657
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/07/2020

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: 11/30/2021
• 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: 02/12/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/12/2020; 10/01/2020; 01/04/2021
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/14/2020; 10/27/2020; 02/10/2021
• 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: 33 YR