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

Model Number	MICL13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unk, unk, unk, unk, unk, unk.Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
A 13.2mm, micl13.2, -13.50 diopter, implantable collamer lens was returned damaged.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
Additional info received on 02 oct 2020: b5: the reporter indicated that a 13.2mm, micl13.2, -13.5 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2020.The lens was removed within the same surgery due to lens tear/break before/during loading.It was reported that a replacement lens was implanted.Additional information has been requested.If additional information is received a supplemental medwatch report will be submitted.H6- work order search: no similar complaint type events were reported for units within the same lot.H3- device evaluation : lens was returned in liquid, inside a vial.Visual inspection found the optic and one of the haptics torn.Residue on lens surface was also observed.Claim# (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated that a 13.2mm, micl13.2, -13.5 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2020.It was reported that upon implantation it was noted that the lens was torn.The lens was removed, and the backup lens was implanted within the same surgery.There was no patient injury.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10570959
• Report Number: 2023826-2020-02259
• Device Sequence Number: 11521430
• Product Code: MTA
• UDI-Device Identifier: 00841542103367
• UDI-Public: 00841542103367
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/02/2020; 11/07/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/29/2020; 01/01/2021
• 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: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK
• Patient Age: 34 YR