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

Model Number	MICL 13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Corneal Edema (1791); No Code Available (3191)
Date of Event	02/13/2020
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, micl13.2, -13.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2020.Excessive vault and corneal edema were observed.The lens was intraoperatively removed with enlargement of pi and yag.Cause of the event is reported as patient related factor.On patient's (b)(6) 2020 "mild persistent corneal edema observed and patient considering placing small icl." per the surgeon on (b)(6) 2020, "patient prefers to use glasses and contact, not to attempt another icl surgery.".
Additional Manufacturer Narrative
Corrected data: b5 -"postoperative report indicated patient had a loss of bcva, from 20/20 to 20/50." should be removed from supplemental medwatch report #1.B5 - on (b)(6) 2020 the reporter indicated patient had enlarged pi (yag) surgery performed 1-2 hours after implant.Surgeon then explanted the lens on the same date and indicated "i enlarged the pi's in both eyes to insure they were patent but this did not lead to deepening of the anterior chamber over the next hour.I felt that she was at great risk for pupillary block and felt removal was the safest course".H6 - h6 - patient code 3191: no code available ( loss of bcva,) should be removed from supplemental medwatch report #1.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 - patient also experienced narrow angles even though they had normal iop.Postoperative report indicated patient had a loss of bcva, from 20/20 to 20/50.H6 - patient code 3191: no code available ( lens explant, yag, narrow angles, loss of bcva) claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: g4 - date received by manufacturer: 18-feb-2020 should be corrected to 17-feb-2020 in intial medwatch report.Claim#: (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned dry, inside a pouch with clear surgical residue on the lens.Visual inspection found the lens haptic deformed and residue on the lens.Additional information: d10 - returned to manufacturer: (b)(6) 2020.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
• MDR Report Key: 9824672
• Report Number: 2023826-2020-00424
• Device Sequence Number: 1551616
• Product Code: MTA
• UDI-Device Identifier: 00841542103350
• UDI-Public: 00841542103350
• Combination Product (Y/N): N
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 05/12/2020; 05/12/2020; 05/15/2020; 05/29/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/12/2020; 05/13/2020; 05/15/2020; 05/29/2020
• 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: 32 YR