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	Intraocular Pressure Increased (1937); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent cataract surgery on (b)(6) 2021 for the right eye (od) and it was implanted with a monofocal intraocular lens (iol).The iol was prepared with ophthalmic viscosurgical device (ovd) from another manufacturer.No surgical complications were reported.On (b)(6) 2012 the patient was examined (day 1 post-operative) and presented an intraocular pressure (iop) of 16mmhg (-7 mmhg from the baseline).The uncorrected distance visual acuity (ucdva) was 1.00 and the patient presented retinal pigment epithelium (rpe) changes.On (b)(6) 2021, during the one week post-operative visit, the patient presented an iop of 36 mmhg (13mmhg from the baseline), a manifest refraction of 0.75 -1.5 92°.The best corrected distance visual acuity (bcdva) was 1.00.The patient was diagnosed with elevated increased intraocular pressure (iop)/ocular hypertension and still presented rpe changes.The patient was hospitalized from (b)(6) 2021 and the following medications were administered: alphagan and diamox.On (b)(6) 2022, during the 6th month post-operative visit, the patient presented an iop of 25mmhg (2 mmhg from the baseline), a manifest refraction of 1.0 -2 84° and a bcdva of 1.00.The patient was diagnosed with posterior capsule opacification and tortuositas.On (b)(6) 2022, during the 12th month post-operative visit, the patient's od iop was 25mmhg (2 mmhg from the baseline).The patient presented a manifest refraction of 0.75 -1.5 78° and the bcdva was 0.80.The posterior capsule opacification and tortuositas persisted.No culture test was taken and no additional surgical intervention was performed.Through follow-up, we learned that the patient is fully recovered.No further information was provided.
Additional Manufacturer Narrative
Section a2, 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 b3 - date of event: unknown/not provided, as information was asked but it was not provided.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: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.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: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.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: 19745877
• Report Number: 3012236936-2024-000181
• Device Sequence Number: 6579406
• Product Code: HQL
• UDI-Device Identifier: 05050474621824
• UDI-Public: (01)05050474621824(17)240816
• 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: 2021
• 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: 08/16/2024
• Device Model Number: GAB00
• Device Catalogue Number: GAB0000220
• 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: 08/16/2021
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White