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

Model Number	MA60MA
Medical Device Problem Codes	Defective Device (2588); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that a lens was found to be damaged on its surface and not have a typical stripe when grasped by the clamp or plunger.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned posterior surface up in the lens case.A large amount of viscoelastic was dried in the lens case and on the lens.One haptic was bent distal area and gusset area.There was a small tear at the haptic insertion area.The lens was cleaned with klrp.The optic has a large scrape mark on the posterior surface.The posterior optic edge is also scraped.Small scratches and cracks are observed near the optic edge which appear to have been cause by an instrument used to grasp the lens.The returned product matched the provided photo.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The returned lens was damaged.A large scrape mark was observed on the posterior surface and posterior edge.The root cause for the observed damage could not be determined.The observed damage is similar in appearance to damage that may occur during delivery if the instruction for use (ifu) is not followed.Other damage was also observed which appeared to be cause by an instrument used to grasp the lens.Associated products were not provided.It is unknown if qualified products were used.The company lens model is only qualified for use in the company cartridge.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 also 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 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: 16753113
• Report Number: 9681121-2023-00003
• Device Sequence Number: 8576879
• Product Code: HQL
• UDI-Device Identifier: 00380652240123
• UDI-Public: 00380652240123
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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.000
• Device Lot Number: 31507265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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
• Patient Sex: Unknown