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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm, micl13.2, -11.50 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2018.On (b)(6) 2018 the lens was exchanged for shorter length lens due to observation of excessive vault and significant reduction of irido-"corenal" "angels".The exchange resolved the problem.Cause of event was reported as patient related factor.It was reported to be believed patient wtw was accurately measured, but that their sulcus-to-sulcus length was lower than average given wtw value.Patient is doing well.
Additional Manufacturer Narrative
Device evaluated by mfr - device evaluation: lens was returned dry, in specimen cup.There was clear surgical residue on product.Visual inspection found residue on lens and the lens returned in pieces and stuck together, unable to evaluate.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: 8199955
• Report Number: 2023826-2018-01888
• Device Sequence Number: 16664318
• Product Code: MTA
• UDI-Device Identifier: 00841542103329
• UDI-Public: 00841542103329
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/28/2018

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: 02/28/2019
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/25/2019
• 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: INJ: NANOPOINT, LOT# 176501; OVD TYPE: PROVISC; INJ: NANOPOINT, LOT# 176501; OVD TYPE: PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR