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

Model Number	MA60AC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Endophthalmitis (1835); Hypopyon (1913); Inflammation (1932); Capsular Bag Tear (2639); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A nurse reported that during a cataract extraction and intraocular lens (iol) implant procedure in the right eye, ophthalmic irrigation and aspiration tip, viscoelastic, and a 3-piece lens were used; the primary incision site clear cornea was 2.4 size, and during surgery a posterior capsular tear occurred with the 3-piece lens, leading to enlargement of the primary incision to 2.75 size with no sutures, wound integrity was intact and negative with no postoperative subconjunctival infection, and postoperative medication drops included antibiotics, steroids, and non-steroidal anti-inflammatory drugs, with it being unknown if the event had resulted in clinically significant visual changes; post-surgery on third day post op less than 14 days later, the patient was diagnosed with endophthalmitis (infectious) and toxic anterior segment syndrome (tass) (2+) with conjunctival inflammation (1+), aqueous cells (2+), and hypopyon, the patient had no pain and the pupil was normal but experienced corneal edema and lid swelling; next day a culture sample was taken and the result was negative, and on the same day the patient was seen by retina and vitrectomy with anterior chamber wash was performed and intracameral (ic) antibiotics were given, the intervention was effective and the current condition of the patient was continuing but improving, with the surgeon¿s opinion being unable to determine if the manufacturer products caused or contributed to the event.This report pertains to one patient from the two patients from the same facility.
Additional Manufacturer Narrative
Corrected information was provided in h.11.Upon receipt of new information for this event, it was confirmed that a duplicate submission had been made for the same reported issue under 9681121-2026-00032.Therefore, no further updates or follow up reports will be submitted under this number 9681121-2025-00193.All future information and reportable updates related to this event will be captured and submitted under the primary report, 9681121-2026-00032.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 23850515
• Report Number: 9681121-2025-00196
• Device Sequence Number: 15846002
• Product Code: HQL
• UDI-Device Identifier: 00380652552547
• UDI-Public: (01)00380652552547(17)291209(11)241211(10)31585858
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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 Model Number: MA60AC
• Device Catalogue Number: MA60AC.210
• Device Lot Number: 31585858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 12/11/2024
• 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: BETADINE; BETADINE 5%; CENTURION SURGICAL PROCEDURE PAK; CUSTOM-PAK SURGICAL PROCEDURE PACK; DISPOSABLE POLYMER IRRIGATION AND SILICONE TIPS; LIDOCAINE; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; PHENYLEPHRINE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; TETRACAINE; VIGAMOX; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Male