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

Model Number	TMICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(expiration date): unk, no serial number reported.(device manufacturing date): no serial numbers reported.(b)(4).
Event or Problem Description
Vault was reporter in the right eye (od) of a patient with an implantable collamer lens.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5: the reporter indicated that a 13.2mm, tmicl13.2, -11.0/1.0/128 (sphere/cylinder/axis) implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2022.Pupil block with elevated iop, pigment dispersion, fixed pupil, iris atrophy, was observed.On (b)(6) 2022, the lens was explanted.In the reporter opinion the cause of this event was reported as other, the reporter stated "fixed dilated pupil, two weeks post icl.Iop slightly elevated, thought might be pupillary block.Pigment dispersion noted, thought might be due to pressure spikes not in office.Now think moxi-dex (5mg/cc) might be case." additional surgical intervention (enlargement of pi yag, additional suture and attempt to exchange) was performed.For status of the eye (signs/symptoms) the reporter stated "phakic without icl implanted.Iris trauma temporally, suture in place, now with mr of -12.75 +1.75x119.Three diopter shift.Waiting to settle to see if proceed with secondary implant.For additional information the reporter stated "first case of iris atrophy.Was concerned it was iop related to high vault.Additional pi enlargement no help.Progressive tid decided to exchange icl.Very difficult case, with induction level anesthesia needed, still not able to keep patient still.Lucky to get lens out.Iris trauma/prolapse.Attempted to placed, then patient began to aspirate, fortunate to be done with case.Contemplating secondary icl under general anesthesia but want refraction to stabilize.Attempted to implant tmicl 12.6 -11.0/1.5/109 (only one avail urgently) sn: (b)(6)." h6- health effect- clinical code 4581: pigment dispersion, unreactive/fixed pupil, iris atrophy, transillumination iris defects.H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
H6- device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim # (b)(4).
Additional Manufacturer Narrative
Correction: h6 - health effect clinical code: 4581 - dilated pupil, iris trauma/prolapse.Should have been included.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14116256
• Report Number: 2023826-2022-01185
• Device Sequence Number: 2427561
• Product Code: QCB
• UDI-Device Identifier: 00841542109154
• UDI-Public: 00841542109154
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/16/2022

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: 10/31/2022
• Device Model Number: TMICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 05/04/2022; 05/26/2022; 09/14/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/06/2022; 09/06/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female