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

Model Number	ZCB00
Medical Device Problem Codes	Material Fragmentation (1261); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Corneal Edema (1791); Macular Edema (1822); Red Eye(s) (2038); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: unknown, information not provided.Ethnicity: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2021 and (b)(6) 2021.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was implanted into patient's left eye without any problem.However, post-operative examination revealed a migrated haptic.The lens was explanted and another johnson & johnson lens (same model and diopter) was implanted as a replacement.No further information was available.
Additional Manufacturer Narrative
Additional information: section b3: date of event: (b)(6) 2021.Section b5: additional information received revealed that the uncorrected vision 1 day post operation (b)(6) 2021) was 20/70, ph to 20/30.On (b)(6) 2021, patient had 20/30 uncorrected and an undilated exam was unremarkable.However, on (b)(6) 2021, patient presented with a 2 day history of pain, redness and decreased vision.She was 20/100 uncorrected and with autorefraction.Additionally, she had an iol (intraocular lens) haptic visible in the pupil space, as well as cystoid macular edema (cme).On the next day in the operating room, the haptic was noticed to be fully separated from the optic and was removed.The remainder of the iol too was removed and the replacement lens was placed in the bag.However, since then patient continues to have cme and residual corneal edema.The best corrected acuity on (b)(6) 2021 was 20/200.The patient will be seeing a retina specialist for the cme and the surgeon may likely refer her to a cornea specialist for evaluation if the corneal edema hasn't improved significantly.No other information was provided.Section h6: health effect - clinical code: 1822 - macular edema.Section h6: health effect - clinical code: 2038 - red eye(s).Section h6: health effect - clinical code: 1791 - corneal edema.Section h6: health effect - clinical code: 2138 - visual impairment.Section h6: medical device problem code: 1261 - material fragmentation.Device evaluation: product testing could not be performed since the product 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 revealed that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12652638
• Report Number: 2020664-2021-07719
• Device Sequence Number: 4490004
• Product Code: HQL
• UDI-Device Identifier: 05050474531697
• UDI-Public: (01)05050474531697(17)250424
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2025
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000190
• 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: 09/20/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2021
• 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 Sex: Female
• Patient Race: Black Or African American