MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A surgeon reported that following an intraocular lens (iol) implant procedure, the patient corneal condition has changed and iol opacification occurred.The iol exchange is planned.Additional information has been requested.
Event or Problem Description
Additional information received and stated that, the iol was exchanged for another lens model 12 years following the initial implant procedure.The symptoms were resolved to the patient.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.A clinical review was conducted of the provided photo.The photograph presents a single two-dimensional anterior segment ocular image under direct slit-beam illumination.The slit beam illumination originates from the right, casting a relatively vertically oriented approximately 4 mm wide parallelepiped illumination from roughly 12 to 7 o¿clock.The photograph presents a single two-dimensional anterior segment ocular image under direct slit-beam illumination.The slit beam illumination originates from the right, casting a relatively vertically oriented approximately 4 mm wide parallelepiped illumination from roughly 12 to 7 o¿clock.Of significance to the reported event described above, the photo illustrates multiple small, gray-colored small opacities extending centrally approximately 1 mm from the pupil margin from 8 to 10 o¿clock.The view of these findings is slightly blurred.A hazy appearance is evident within the parallelepiped optical section.The image within this section is blurred.The image to the right of the parallelepiped optical section is blurred.The precise location(s) of findings, relative to the iol (intraocular lens) could not be determined due to the blurred illustration of these findings (i.E., anterior to the iol, anterior lens capsule, anterior iol surface, within the iol, posterior iol surface, posterior lens capsule and/or posterior to the iol).As a result of the findings stated above, the photograph cannot conclusively confirm the reported iol opacification.The product investigation could not identify a root cause for the reported complaint.Information was provided that the non-toric company, 18.0 diopter lens was implanted on (b)(6) 2010.The patient's corneal condition had changed.The iol exchange procedure (b)(6) 2022 was with a non-company toric lens.The photo review indicated multiple, gray-colored small opacities observed, extending centrally approximately 1 mm from the pupil margin from 8 to 10 o¿clock.A hazy appearance was evident within the parallelepiped optical section.The image within this section was blurred.The image to the right of the parallelepiped optical section was blurred.As a result of the findings stated, the photograph cannot conclusively confirm the reported iol opacification.The sample has not been returned.File will be reopened if the sample is received at the manufacturing site.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned wrapped in surgical gauzes.The optic was cut into pieces, typical of insertion and removal.The lens was cleaned with klrp (kl-related protein) for further evaluation.The lens appears clear.Power and resolution testing could not be conducted due to the extensive optic damage.A clinical review was conducted of the provided photo by a director with gqca (global quality customer affairs).The photograph presents a single two-dimensional anterior segment ocular image under direct slit-beam illumination.The slit beam illumination originates from the right, casting a relatively vertically oriented approximately 4 mm wide parallelepiped illumination from roughly 12 to 7 o¿clock.The photograph presents a single two-dimensional anterior segment ocular image under direct slit-beam illumination.The slit beam illumination originates from the right, casting a relatively vertically oriented approximately 4 mm wide parallelepiped illumination from roughly 12 to 7 o¿clock.Of significance to the reported event described above, the photo illustrates multiple small, gray-colored small opacities extending centrally approximately 1 mm from the pupil margin from 8 to 10 o¿clock.The view of these findings is slightly blurred.A hazy appearance is evident within the parallelepiped optical section.The image within this section is blurred.The image to the right of the parallelepiped optical section is blurred.The precise location(s) of findings, relative to the iol could not be determined due to the blurred illustration of these findings (i.E., anterior to the iol, anterior lens capsule, anterior iol surface, within the iol, posterior iol surface, posterior lens capsule and/or posterior to the iol).As a result of the findings stated above, the photograph cannot conclusively confirm the reported iol opacification.Product history records were reviewed and documentation indicated the product met release criteria.The attached photo was reviewed by a director with gqca (global quality customer affairs).The photo review indicated multiple, gray-colored small opacities observed, extending centrally approximately 1 mm from the pupil margin from 8 to 10 o¿clock.A hazy appearance was evident within the parallelepiped optical section.The image within this section was blurred.The image to the right of the parallelepiped optical section was blurred.As a result of the findings stated, the photograph cannot conclusively confirm the reported iol opacification.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13363928
• Report Number: 1119421-2022-00115
• Device Sequence Number: 14315897
• Product Code: HQL
• UDI-Device Identifier: 00380655093153
• UDI-Public: 00380655093153
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/13/2022

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: 01/31/2015
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.180
• Device Lot Number: 11005532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 02/08/2022; 03/18/2022; 04/19/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 02/24/2022; 04/13/2022; 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female