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

Model Number	ZCU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
The account reported a planned explant of a toric intraocular lens (iol) due to refractive surprise (myopic shift) despite using optiwave refractive analysis (ora) at original surgery.The patient also experienced diplopia for two (2) months and shadowing.It was confirmed that the patient is not debilitated.It was indicated that the issue was not due to calculation error.The original lens was with a residual prescription (rx) -1.00 -0.50 x138.Target was plano (0.00).Patient was reported status post (s/p) myopic lasik in both eye (ou).Biometry and topography were not obtained post-op.No patient injury was reported.Through follow ups, it was learned that the lens was explanted on (b)(6) 2024.Another johnson & johnson lens of the same model, but of a lower diopter (19.5 d) was implanted in the patient¿s right eye as a replacement iol.No other medical/surgical intervention required.The patient is doing well, seeing 20/25 with post operative expected findings at 1-day post op.No further information was provided.This emdr report pertains to patient's right eye (od).No complaint with the patient's left eye (os) reported.
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.Section b3: date of event: unknown, not provided, but the best estimate date is between may 7, 2024 and jul 16, 2024.Section h6: health effect - clinical code: 2138 diplopia-transient, 2138 unexpected postop refraction.Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints were received for this po.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Attempts were made to obtain missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• 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: 19925071
• Report Number: 3012236936-2024-000210
• Device Sequence Number: 8234927
• Product Code: HQL
• UDI-Device Identifier: 05050474657809
• UDI-Public: (01)05050474657809(17)270625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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 Model Number: ZCU150
• Device Catalogue Number: ZCU150U205
• 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: 07/17/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2022
• 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: 69 YR
• Patient Sex: Male