MAUDE Adverse Event Report: PT. CIBA VISION BATAM ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number	MA60MA
Medical Device Problem Codes	Product Quality Problem (1506); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure after implantation the surgeon noticed a defect on the lens also, one of the haptics was noted to be bent after implantation.The lens was removed during initial procedure and replaced with company lens.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge and handpiece.The file also indicates the use of a non qualified viscoelastic.The product was not returned.The root cause for the reported complaint may potentially be related to a failure to follow the instructions for use (ifu).A non qualified viscoelastic was used.The viscoelastic indicated is not qualified for the lens or company combination used.Company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs: use holding forceps to grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd filled cartridge.The lens should be inserted until it is centered with or slightly past the outline etched into the top of the cartridge.Lenses with a 6.5 mm optic diameter may need to be pre-folded for easy entry into the back of the cartridge.Lens may be pre folded by gently applying pressure to the edge of the lens while holding the central optic with forceps the trailing haptic will extend from the proximal end of the cartridge.Position the trailing haptic to the left of the haptic post as shown in the detailed view.This will allow the plunger to go past the haptic during the initial advancement of the plunger into the cartridge.Verify the lens is positioned on the bottom surface of the cartridge.The haptic should be maintained to the left of the post when the lens is loaded correctly.Accurate positioning of the lens will decrease the potential for optic and haptic damage.File will be reopen if the product is returned or new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h11.The lens was returned positioned incorrectly in the lens case.Viscoelastic was observed on both sides of the optic.The lens had been cut into two pieces typical of a removal.One haptic was broken in two places, pieces returned.The distal portion was also crimped.The gusset area also had scraped/crimped damage.The lens was cleaned with klrp.The optic was damage near the insertion are of the damaged haptic.Forceps marks were observed at the optic edge.This appears to be removal damage.The used company cartridge was also returned.Inadequate viscoelastic was observed in the cartridge.The cartridge had evidence of placement into a handpiece.No cartridge damage observed.The used company cartridge was cleaned for further evaluation.Top coat dye stain was conducted with acceptable results.A device history record review and a nonconformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.A qualified cartridge and handpiece were used with a non qualified viscoelastic.The root cause for the reported complaint may potentially be related to a failure to follow the instructions for use (ifu).A non qualified viscoelastic was used.In addition, inadequate viscoelastic was observed in the cartridge.The optic and haptic damage observed may also indicate a plunger override occurred.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The ifu instructs: use holding forceps to grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until it is centered with or slightly past the outline etched into the top of the cartridge.Lenses with a 6.5 mm optic diameter may need to be pre-folded for easy entry into the back of the cartridge.Lens may be pre folded by gently applying pressure to the edge of the lens while holding the central optic with forceps.The trailing haptic will extend from the proximal end of the cartridge.Position the trailing haptic to the left of the haptic post as shown in the detailed view.This will allow the plunger to go past the haptic during the initial advancement of the plunger into the cartridge.Verify the lens is positioned on the bottom surface of the cartridge.The haptic should be maintained to the left of the post when the lens is loaded correctly.Accurate positioning of the lens will decrease the potential for optic and haptic damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer (Section G): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22086175
• Report Number: 9681121-2025-00049
• Device Sequence Number: 12496659
• Product Code: HQL
• UDI-Device Identifier: 00380650699244
• UDI-Public: (01)00380650699244(17)290512(11)240514(10)31573775
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2025

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 Model Number: MA60MA
• Device Catalogue Number: MA60MA.010
• Device Lot Number: 31573775
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 09/30/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/19/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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: AMVISC.; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE A.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Patient Age: 60 YR
• Patient Sex: Female