MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SMARTLOAD; INTRAOCULAR LENS

Model Number	GAB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Hyperemia (1904); Hyphema (1911); Inflammation (1932); Unspecified Eye / Vision Problem (4471)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, the patient underwent cataract surgery in the left eye (os) and the monofocal intraocular lens (iol) 17.5d was implanted.The iol was prepared with ophthalmic viscosurgical device (ovd) from another manufacturer.No surgical complications occurred.The following was performed a suture canalopasty, a suprachoroidal drainage, ologen implant (6mm).The patient was hospitalized.On february 8, 2022 the patient was examined and presented an intraocular pressure (iop) of 12 mmhg (-7 mmhg from the baseline).The uncorrected distance visual acuity (ucdva) was hand movement.The patient also presented conjuctival hyperemia/injection and dry eye/superficial punctate keratopathy/punctate epithelial erosion/tear film insufficiency; and cells in the anterior chamber.The patient also presented an iris base tear.On (b)(6) 2022, the patient was discharged.The hyphema resolved without sequelae.Through follow-up, we learned that the patient is fully recovered.No further information was provided.
Additional Manufacturer Narrative
Section a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6b - explant date: not applicable, lens remains implanted.Section e1 - email address: unknown/not provided, as information was asked but it was not provided.Section e1 - telephone number: (b)(6).Device evaluation: the intraocular lens was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device could not be performed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain the missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SMARTLOAD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19746879
• Report Number: 3012236936-2024-000197
• Device Sequence Number: 6532152
• Product Code: HQL
• UDI-Device Identifier: 05050474621732
• UDI-Public: (01)05050474621732(17)240921
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

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: 09/21/2024
• Device Model Number: GAB00
• Device Catalogue Number: GAB0000175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White