MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA LENS; INTRAOCULAR LENS

Model Number	621P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the risk assessment for the lucia product, and based on our experience and other complaints that have already been resolved, we have determined that the following factors may have caused or contributed to the damaged haptic issues, are but not limited to: · improper folding of the lens.The lens should fold "u" during the advancement of the plunger.In some cases, misplacement of the lens may occur within the cartridge when adding ovd, the cannula may catch the edge of the lens or haptic; thus, removing the lens off the "track." this causes the lens to not eject correctly, resistance being felt or appear to become stuck.· inadequate application of ovd.The ifu asks for generous amount of ovd to be applied, which covers the lens and the blue cushion.If ovd is not placed on the blue cushion advancement of the plunger, it may be inhibited by high frictional force and appear to become stuck.· dwell time after preparation: the ifu recommends that after the lens is advanced into the conical section, the lens must be injected immediately.Dwell scenarios where the lens sits in this position for a prolonged time prior to injection may lead to stuck iol issue.Viscoelastic materials may lose their lubricity if allowed to stand too long.For 621p- dwell time after preparation: the ifu indicates that after you cover the whole lens and blue plunger tip with a generous amount of ophthalmic viscoelastic, avoid touching the lens and blue plunger tip.You are to close the lid of the iol chamber, and allow the lens to remain in this position until the surgeon is ready to implant it into the eye.Then you are to advance the lens to the intermediate position.Gently press the plunger forward until an audible "click" is heard.The ifu gives the following statement: "important: the lens should be implanted immediately.Dwell scenarios where the lens sits in this position for a prolonged time prior to injection may lead to stuck iol issue.Viscoelastic materials may lose their lubricity if allowed to stand too long.".
Event or Problem Description
On (b)(6), 2023 the doctor had a complication with a 621p iol in which the haptic broke during insertion of the iol.It was stated by the customer that there was no damage noted to the device during preparation for use.Upon insertion of the lens, the delivery device was about to be removed when the view of the haptic was detached from the optic.At this time, the doctor removed the delivery device and began to remove the haptic and lens.The customer stated there was a delay in removal of both the haptic and the optic.The lens was successfully removed with no complication.The lens was replaced with another zeiss lens.

• Brand Name: CT LUCIA LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): CARL ZEISS MEDITEC PRODUCTION LLC; 1040 s. vintage ave. bld. a; ontario CA 91761
• Manufacturer (Section G): CARL ZEISS MEDITEC PRODUCTION LLC; 1040 s. vintage ave. bld. a; ontario CA 91761
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 17391113
• Report Number: 3010126268-2023-00090
• Device Sequence Number: 17851166
• Product Code: HQL
• UDI-Device Identifier: 00843045102274
• UDI-Public: (01)00843045102274(11)230508(17)241031
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P10016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2023

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: 10/31/2024
• Device Model Number: 621P
• Device Catalogue Number: 003500-0056-481
• 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: 06/28/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown