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

Model Number	MA60AC
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported with a description of the intraocular lens cracked in half upon insertion.Additional information was requested.
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).
Additional Manufacturer Narrative
Additional information was provided in a1., a2., a3.A, b.3., b.5., d.10.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the lens was removed during initial procedure.No patient harm was reported.
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.No similar complaint and no non-conformance reported for the product lot or batch or serial under investigation the product investigation could not identify a root cause for the reported complaint.The product has not been returned to evaluate.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: 19836532
• Report Number: 9681121-2024-00034
• Device Sequence Number: 20495098
• Product Code: HQL
• UDI-Device Identifier: 00380652552585
• UDI-Public: (01)00380652552585(17)280729(11)230801(10)31551147(21)31551147057
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2024

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: MA60AC
• Device Catalogue Number: MA60AC.230
• Device Lot Number: 31551147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 08/13/2024; 09/26/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/09/2024; 10/24/2024
• Date Device Manufactured: 08/01/2023
• 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: HEALON GV.; UNSPECIFIED LENS FOLDING FORCEPS.; UNSPECIFIED LENS INSERTING FORCEPS.
• Patient Age: 60 YR
• Patient Sex: Female